STERILIZATIONRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. All cleaning should be performed in a manner designed to minimize exposure to bloodborne pathogens. Irritational injury of soft tissues, including impingement syndrome. Packaged and sterilized instruments should be stored in an area that provides protection from dust moisture, insects, vermin, and extremes of temperature and humidity. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. Extreme care must be taken when following the technique for the removal of the device. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). The DynaNail Hybrid shares universal instrumentation with the DynaNail Mini to provide surgeons with intraoperative ease and flexibility. Use flowing water and disposable wipes to remove excess soil. Demonstrated psychological instability, inappropriate motivation or attitude. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. The DynaNail Helix Fixation System components manufactured by DJO must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. Drill a lateral-to-medial hole into the calcaneus through the proximal calcaneal hole across the DynaNail implant and insert a 5mm Headed Cortical Screw1. To minimize possible interference risks during medical imaging such as magnetic resonance imaging (MRI), advise the patient to mention that he/she was implanted with a metallic device. Ensure that all blood, saline, and traces of tissue are removed. The DynaNail Helix Ancillary Surgical Instruments are provided NON-STERILE. Repeat rinsing step using distilled. A thorough manual or combination manual/automated cleaning process is required. Place the End Cap into the distal end of the DynaNail Implant and close the incision per surgeon preference. For manual washing, DJO recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. The DynaNail Mini Fusion System components manufactured by MedShape must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. Hybrid screw/nail design of the DynaNail Hybrid combines sustained dynamic compressive power with easy, intuitive insertion. Never attempt to reuse. The healthcare facility isresponsible for maintaining water quality that is compliant with AAMI TIR34. Consult Instructions For Use. Contact Customer Service or an authorized MedShape representative to receive a return authorization number prior to return shipment. *With the Guide Sleeve placed through the appropriate distal side hole of the Nail Targeting Assembly and abutted to the bone surface, use the Drill Guide and Transverse Screw Drill to drill a pilot hole through the distal screw hole in the DynaNail Mini Implant. The DynaNail TTC Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. Patients should be cautioned against unassisted activity that requires walking or lifting.Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. With the numbered Compression Wheelset to 0, fully stretch the Compressive Element by pulling down on the lever. The DynaNail TTC Fusion Nail is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Limited Liability:The DynaNail Mini Fusion System Components are guaranteed for materials, function, and workmanship for a single patient use. Skeletally immature patients where the implant would cross open epiphyseal plates. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Lacks an understanding that a metallic implant is not as strong as normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it. The DynaNail Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle. Repeated reprocessing has minimal effect on the devices. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. the dynanail mini fusion system in extended lengths was designed for use in midfoot reconstruction procedures and features patented and proven superelastic internal nitinol compressive element technology now miniaturized to accommodate smaller bone anatomy 2,3unlike traditional beaming devices that lose compression within 1 mm of bone All instruments should be thoroughly cleaned. CONTRAINDICATIONS Patients with an active local or systemic infection. Subtalar fusion surgery is performed to relieve pain and correct severe foot deformity by achieving a solid bony union. The DynaNail Mini Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. Prevaccuum/Pulsating Vacuum/FlashAutoclave, SO 15223-1 Medical Devices Symbols To Be Used with Medical Device Labels, Labeling, and Information To Be Supplied. 4. Nucleus visually depicts the main surgical steps involved while . Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. on DJO DynaNail Helix Fixation System Instruction Manual, CLEANING AND STERILIZATION PROCEDURES (DEPLOYMENT FRAME AND ANCILLARY SURGICAL INSTRUMENTATION ONLY), DJO PROCARE Pre-Vent Ulnar Nerve Protector Instructions. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect and/or consequential damages of any kind and however caused arising from the sale or use of the product. Prior to surgery, the surgeon should discuss with the patient all possible risks versus potential benefits of treatment considering the patients preoperative condition and expectations for improvement in his/her condition postoperatively. Keep instruments moist after use to prevent soil from drying on them. Lester ELECTRICAL ChargerConnect App User Guide, mXion PWD 2-Channel Function Decoder User Manual, amber connect ANC200 Instant C200 Cigarette Lighter GNSS Tracker User Guide, mXion RD6 6-Channel Relay Decoder User Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. The quality of water should be carefully considered for use in cleaning reusable devices. Additional MedShape Cleaning Instructions. Keep instruments moist after use to prevent soil from drying on them. Insert the Fusion Nail into the pre-drilled hole, and advance the nail fully. Scanning a patient who has this medical device may result in patient injury. According to ANSI/AAMI standards ST79:2017, the accepted standard for the degree of cleanliness is visibly clean. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. If evidence suggests a loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities. Ensure that the pack is large enough to contain the instrument without stressing the seals. The DynaNail Mini Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. The DynaNail Deployment Frame and the Ancillary Surgical Instruments should be fully disassembled into component parts prior to cleaning. Prior to surgery. When utilizing an automated cleaner follow equipment manufacturers instructions for use, incorporating low foaming. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. To detect any residual blood or protein particulates that may be trapped in visually obstructed areas, the instrument may be submerged in a 2% hydrogen peroxide solution. Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. Handling of the DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. Never attempt a surgical procedure with defective, damaged or otherwise compromised instruments or implants. Handling of the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. Single: A standard packaging material may be used. Indicates a medical device that has been sterilized using irradiation. The DynaNail Mini Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. Additional MedShape Cleaning Instructions. Rigid sterilization container that complies with ANSI/AAMI ST46. Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. and sterilized prior to surgical use. Ensure that cutting / sharp edges are protected. Has immunological responses, sensitization, or hypersensitivity to foreign materials. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. . Contact DJO customer service for replacements. In Sets: Load DJO Surgical Instruments into the appropriate instrument trays. Rinse instruments following exposure to hydrogen peroxide. DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. Featuring MedShape's patented superelastic nickel titanium (NiTiNOL) technology, the DynaNail Mini is the first orthopaedic device designed specifically for subtalar fusion that offers maintained . 6. The DynaNail Helix Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The use of abrasive compounds or excessively acidic or alkaline solutions may cause damage to the instruments and should be avoided.7. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Use care in handling and storage of the instruments. Failure to immobilize the site during healing may result in bending and/or breakage of the device and/or failed fusion. In Sets: Load MedShape Surgical Instruments into the appropriateinstrument trays. Do not add other instruments to the DynaNail Helix Instrument Tray that are not part of the standard configuration supplied by DJO. Background Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. The appearance of bubbles confirms. The DynaNail was introduced clinically in 2012. To learn more about what we collect and how we use that information, or to change your privacy settings see our Privacy Policy. CleaningThe DynaNail Deployment Frame and each Ancillary Surgical instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. The DynaNail TTC Fusion System components manufactured by MedShape must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: It is the responsibility of the surgeon to provide the patient with appropriate information prior to surgery. 4 kontraindikasi. The company claims it is the "first and only internal fusion device to harness the pseudoelastic properties of NiTiNOL (nickel titanium) to provide the compression performance of an external frame inside an IM nail design. DESCRIPTION. DynaNail Mini is a trademark of MedShape, Inc. DynaNail and DynaClip are registered trademarks of MedShape, Inc. 1 Dupont KM, Shibuya N, Bariteau JT. Manage SettingsContinue with Recommended Cookies, MEDSHAPE DynaNail Mini Fusion System Instruction Manual 1. pipe cleaner, or appropriately sized guidewire. Hear from patient Teri Sutherland about her experience and recovery after undergoing a procedure with MedShape's DynaNail Mini. The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. Store the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer in a dry place at room temperature (20C to 25C). Postoperative care and physical therapy should be structured to prevent the loading of the operative extremity until stability is evident. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be best for each individual patient. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility. :http://www.medshape.com/patents.htmlMK-10161 Rev. (DEPLOYMENT FRAME AND ANCILLARY SURGICAL INSTRUMENTATION ONLY). Serious postoperative complications may occur from the use of the implant in a patient who: The DynaNail TTC Fusion Nail has not been evaluated for safety and compatibility in the MR environment. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury.Carefully inspect product packaging and all device components for damage or defects prior to use. Do not use device if it appears defective, damage or otherwise compromised. Each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. Achieves 6 mm of post-operative compression PLUS 6 mm of intra-operative manual compression Provides automatic dynamization upon weightbearing It is the physicians responsibility to determine the correct size of the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer to be implanted. When evaluating patients for implantation using the DynaNail Mini Fusion System, always consider the patients weight, occupation, activity level and the presence of any degenerative disease. Contaminated instruments should be transported to the area for cleaning in a way that avoids contamination of personnel and hospital.1.Use flowing water and disposable wipes to remove excess soil.2.Presoak the instruments with an enzymatic solution for a minimum of five (5) minutes.3Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument.4.Rinse parts under cold (<45C) sterile water for a minimum of one (1) minute.5Repeat the process until no visible debris remains.6.Soak the instruments in Ultra Clean System Low Foam Detergent (pH neutral) for a minimum of one (1) minute. Refer to the Instrument Tray and/or illustration in DJOs Surgical Technique Guide for the completely disassembled components. The DynaNail Deployment Frame and Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. Never attempt to reuse the devices, even though they may appear undamaged. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Refer to the Instrument Tray and/or illustration in MedShapes Surgical Technique Guide for the completely disassembled components. Home DJO DJO DynaNail Helix Fixation System Instruction Manual. Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. Confirm that any moving parts function properly. Once the Fusion Nail, End Cap, and Screws have been removed from the packaging, the device should be either used or discarded. Never attempt to reuse. 1 djo dynanail helix fixation system. Any recommendations provided herein are provided as general guidelines only. Moist heat/Steam is the only method that has been validated for reprocessing by MedShape. Repairs or modifications performed other than by DJO or a DJO authorized repair facility. The DynaNail Mini Deployment Frame and each Ancillary Surgical Instrument must be cleaned in accordance with appropriate healthcare facility procedures prior to sterilization. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. Packaged and sterilized instruments should be stored in an area thatprovides protection from dust, moisture, insects, vermin, and extremesof temperature and humidity. Similar to its larger predecessor, the DynaNail TTC Fusion System, it features MedShape's patented internal superelastic NiTiNOL technology that provides strong joint stability due . imperii Mini SPY Earpiece Instruction Manual, Novlistve 880788509328 Wireless Earbuds Bluetooth Headphones, NEC NP-M322W Smart Digital Projector Users Manual, SOLAX 0148083 BMS Parallel Box-II for Parallel Connection of 2 Battery Strings Installation Guide, LEDVANCE G11151664 Emergency Conversion Box Instruction Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Insert the DynaNail Helix Threaded Bone Fastener into the pre-drilled hole, with or without a DynaNail Helix Washer, and advance the device fully. The appearance of bubbles confirms the presence of protein and the instrument should be re- cleaned. (DEPLOYMENT FRAME AND ANCILLARY SURGICAL INSTRUMENTATION ONLY) These general recommendations are provided as a guide only. Demonstrates physiologic or anatomic anomalies. Use of the implant or system components for these purposes may result in patient injury. Ideally, all components should be cleaned within 30 minutes and after no more than 4 hours of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on the instrument prior to cleaning. The surfaces of the implants must always be protected from damage during handling. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. Serious postoperative complications may occur from use of the implant in a patient who: This device contains NiTiNOL, an alloy of nickel and titanium. Carefully inspect sterile packaging for damage prior to use. The latest addition to DJO's robust suite of foot and ankle products and an expansion of the DynaNail Mini line, the system leverages MedShape's proven active, adaptive healing technology 1 . The DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. NiTiNOL and its pseudoelastic properties have shown to be. The Deployment Frame, Guide Sleeve, and appropriate Drill Guide may be used to target all drills/screws except for the most proximal hole on the 26 cm and 30 cm length DynaNail implants. Use care in handling and storage of the instruments. The DynaNail Mini TTC Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. Never attempt to reuse the Nails, End Cap, and/or Screws, even though they may appear undamaged. Patients with an active local or systemic infection. Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. Just connect the Nail Guide to the Mini Targeting Frame and implant! In the absence of a bursa or pain, removal of the implant in elderly or debilitated patients is not recommended. For best results, always use the largest possible components and ensure that the components are properly positioned. Careful preoperative planning must be conducted. The healthcare facility is responsible for in-house procedures for the reassembly, inspection and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Use only DynaNail Helix Fixation System components. It is the physicians responsibility to determine the correct size of the Fusion Nail and Screws to be implanted. The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. Avoid contacting the implants with other tools or materials that could notch, scratch or otherwise damage the implant surfaces. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedures, and other large bone fusion procedures. 10 barang yang dibutuhkan. DynaNail Mini was introduced in 2019 with 60-100 mm lengths for use in subtalar fusion procedures. The surgeon must make the final decision regarding implant removal. If bubbles were present or instruments were not deemed visibly clean, steps 1-8 of the manual cleaning process should be repeated. The system also features a rigid, radiolucent carbon fiber-filled polyether. Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patients bone or both. Patients with an active local or systemic infection. Modified devices may not perform as intended and could result in patient injury. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Manual cleaning should be done while the instrument is immersed. The DynaNailu00ae Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. It is the responsibility of the user to ensure that the sterilization process is actually performed using qualified equipment, materials, and personnel such that the recommended parameters are achieved. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are designed to be cleaned and steam sterilized following the instructions below. Required fields are marked *. Place your non-custom orders instantly and easily. It has not been tested for heating or migration in the MR environment. Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument. Patients with severe peripheral vascular disease. on MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, 14. The patient should be provided with detailed written instructions regarding postoperative care, and the use and limitations of the device. Call your DJO sales representative for a replacement. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. Manual cleaning should be done while the instrument is immersed. DynaNail is a registered trademark of MedShape, Inc.MedShape, Inc., 2017. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. 2 deskripsi perangkat. Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. Always handle the DynaNail TTC Fusion Nail carefully. NiTiNOL-based DynaNail products approved for use with new ICD-10-PCS code. Sterrad or hydrogen peroxide based gas systems have not been validated. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. Never attempt a surgical procedure with defective, damaged, or otherwise compromised instruments or implants. Patients with severe peripheral vascular disease. Rehabilitation, pain management and healing. Tibiotalocalcaneal Arthrodesis with. Misuse, mishandling, and/or improper operation.b. Failure to immobilize the ankle during healing may result in bending and/or breakage of the device and/or failed fusion. Handling of the DynaNail Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. Sensitivity, allergies, or other reactions to the device material. and sterilized prior to surgical use. Always follow the sterilizer manufacturer recommendations.When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded.The DynaNail Helix Instrument Tray is designed to hold all the Ancillary Surgical Instruments during sterilization. Store the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments in the DynaNail Mini Instrument Caddy. Do not modify the implant. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. 02Issued 03/2021. These specialized instruments are required to correctly perform the DynaNail Helix implantation procedure and to remove the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer if required, following implantation. Bienvenue dans ce guide sur Aseprite et la cration d'asset 2D pour un mini RPG 2D en Pixel Art. Modified devices may not perform as intended and could result in patient injury. Drying times vary according to load size and should be increased for larger loads. Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and. Follow Universal Precautions for handling and transporting contaminated instruments to the designated cleaning area. Contact MedShape customer service for any replacements. Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants, and postoperative patient care and management are essential to a successful outcome. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury. Tissue reactions including macrophage and foreign body reactions adjacent to implants. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Other sterilization cycles may also be suitable, but the individuals or hospitals are advised to validate other methods for use with MedShape products. Loss of fixation in bone attribute to nonunion, osteoporosis and/or markedly unstable comminuted fractures. 7. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. Note: If you have questions concerning the disassembly of the instruments, contact the MedShape Customer Service or your local MedShape sales representative. reverse osmosis or deionized water. Damage to the implants surface finish may result in loss of proper mechanical function of the device. Comment * document.getElementById("comment").setAttribute("id","a87d575584c1f1f56fc44049058b54d9");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Table A. Always follow the sterilizer manufacturers recommendations. The latest addition to DJO's robust suite of foot and ankle products and an expansion of the DynaNail Mini line, the system leverages MedShape's proven active, adaptive healing technology 1 . For more information visit us at https://www . 3. Do not modify the implant. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect and/or consequential damages of any kind and however caused arising from the sale or use of the product. The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. Always handle the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer carefully. The DynaNail Helix Fixation System has not been evaluated for safety and compatibility in the MR environment. Repairs or modifications performed other than by MedShape or a MedShape authorized repair facility.c. Please remove any damaged device or instrument from use and call your DJO sales representative for a replacement. - Kent. Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion must have auxiliary support. The patient should be advised that noncompliance with postoperative instructions could lead to loosening, bending, or breakage of the implant, requiring revision surgery to remove the device. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers following implantation, if required.Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of the DynaNail Helix Fixation System implants. Remove the temporary compression drill and insert a 5mm Cortical Headed Screw. The DynaNail Miniu00ae Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantation. 7 informasi seleksi pasien. Visually inspect all instruments for damage and wear. The DynaNail Helix Fixation System implants includes nickel and titanium materials. The DynaNail Mini Fusion System features MedShape's patented superelastic nickel . Demonstrated psychological instability, inappropriate motivation, or attitude. If the sterile packaging is found to be damaged or open, do not use the device or attempt to re-sterilize. The adequacy of any healthcare facility sterilization procedure must be suitably tested. Patients with foreign body sensitivity suspected or documented metal allergy or intolerance. [emailprotected], Your email address will not be published. The DynaNail Mini Screw is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. Read all package insert warnings, precautions, and instructions. 8 informasi bimbingan pasien. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. Release the Fusion Nail from the Deployment Frame by unscrewing the connection screw. Sensitivity, allergies, or other reaction to the device material. Validated exposure temperature required to achieve a 10-6 sterility assurance level (SAL). Follow the manufacturers instructions for mixing, preparing, and using such detergents. Loosening, bending, cracking or fracture of the implant components. The patient should be advised that noncompliance with postoperative instructions could lead to loosening, bending or breakage of the implant, requiring revision surgery to remove the device. Lacks an understanding that a metallic implant is not as strong as a normal healthy bone and will bend, loosen, or fracture if excessive demand is placed on it. The DynaNail Helix Washer is manufactured from titanium alloy (Ti6Al-4V ELI).The Ancillary Surgical Instruments are specifically designed for use with the DynaNail Helix Fixation System. Carefully select the appropriate DynaNail Mini Screw sizes based on the needs of each individual patient. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. The DynaNail Mini Fusion System has not been evaluated for safety and compatibility in the MR environment. The quality of water should be carefully considered for use in cleaning reusable evinces. 1(5). Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. NOTE: Synonyms for batch code are lot number and batch number.. DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile : Code Information: Model No. 2600-05-006; Lot No. Prolonged exposure to saline may result in corrosion of stainless steel instruments. Avoid contacting the implant with other tools or materials that could notch, scratch, or otherwise damage the implant surface. NOTE: Indicates the manufacturers batch code so that the batch or lot can be identified. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. If evidence suggests loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities.The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. Patients with an active local or systemic infection. Call your MedShape sales representative for a replacement. Prior to implantation, patients should be counseled on the materials contained in the device, as well as the potential for allergy/hypersensitivity to the materials. Required fields are marked *. Store the DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws in a dry place at room temperature (20C to 25C). The physician should always have a full inventory of sterile DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers on hand at the time of surgery to ensure availability of the optimum size for the patient. The DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are provided sterile for single use only. Unlike traditional screws that lose compression post-operatively, the DynaNail Hybrid maintains compression up to 5 mm of bone settling or resorption depending on implant length.1, The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedu. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. Do not rely upon automated cleaning using a washer/disinfector alone as this may not be effective for devices and instruments with cannulations, blind holes, mated surfaces and other complex features. WARNINGSThe DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are supplied sterile for single use only.DO NOT ATTEMPT TO RESTERILIZE. 1. TTC Fusion Nail, DynaNail End Cap, and/or DynaNail Screws following implantation, if required.Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm the correct positioning of implantable DynaNail TTC Fusion System components. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility. Refer to Table A for further cleaning instructions. Serious postoperative complications may occur from use of the implant in a patient who: This device contains NiTiNOL, an alloy of nickel and titanium. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you. Subtalar fusion surgery is performed to relieve pain and correct severe foot deformity by achieving a solid bony union. Do not stack the DynaNail Helix Instrument Trays during sterilization. Containment devices can be stacked for storage. Has immunological responses, sensitization, or hypersensitivity to foreign materials. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. The DynaNail Mini Deployment Frame and each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. The surgeon is responsible for patient selection. The DynaNail Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths. AAMI/AORN steam sterilization cycles with cycle times longer than those listed are also acceptable. Repeat the process until no visible debris remains. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures and other large bone fusion procedures. Refer to Table A for manual cleaning steps. The safety of the DynaNail Mini Fusion System in the MR environment is unknown. Potential adverse effects resulting from the use of the DynaNail TTC Fusion System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision or removal surgery, and/or amputation of the limb. 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