Integra Total Foot System 2

Transcription

1 Instructions for Use CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician. Integra Total Foot System 2 DESCRIPTION The Integra Total Foot System (TFS2) is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Available plates, screws and instrumentation are packaged as a single system and organized around the types of plates described below: Fore Foot Plates 1. Open Wedge Plates The plates are offered with stems ranging from 2-5mm in 0.5mm increments, a 6mm stem, or without a stem. 2. Universal Forefoot Plates The plates are available in 7 sizes: 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, and 30mm. 3. MPJ Fusion Plates The MPJ Fusion Plate is offered in medium and long lengths and left and right configurations. 4. Tarsalis Plates The 2-Hole Straight Tarsalis Plate is offered in short and long lengths. The 3-Hole and 10-Hole Straight Plates are included in the system as standard lengths. The 4- Hole Straight Tarsalis Plate is offered in both standard and short lengths. The Crescentic Tarsalis Plate is offered in left and right configurations. The 4-Hole Diamond Plate is available in left and right configurations. The T-Shaped Tarsalis Plates are offered in 4-hole, 5-hole, and, 6-hole configurations. The 5-hole designs are provided in straight, left, and right configurations. The 6-hole is only provided in straight configuration. OPTIONAL: Upon request, the 6-hole, 7-hole and 8-hole T-Shaped Tarsalis Plates are available. The 6-hole T-Shaped Tarsalis Plate is available in left and right. The 7-hole and 8- hole T-Shaped Tarsalis Plates are only available in left and right configurations. Rear Foot Plates 1. Lapidus Plates The plate is designed with a 0-6mm step in 1 mm increments (7 sizes) to displace the bones. 2. Interpositioning Plates The plate is offered with or without a stem to space apart two bones or a joint, with stems being offered in widths 2-12mm in 2mm increments. 3. Universal Rearfoot Plates The plates are available in 7 sizes: 14mm, 16mm, 18mm, 20mm, 22mm, 24mm, and 30mm.

2 4. Rearfoot Reconstruction Plates The plates are available in 7-hole, 9-hole and 14-hole versions. 5. Flat line Arthrodesis Plates The plates are available in 12mm, 14mm and 16mm sizes. 6. Dwyer Displacement Plates This plate is offered with three different step sizes; 6mm, 8mm, and 10mm 7. Calcaneus Plates The calcaneus plates are available in small, medium, extra small, mini and mini-long sizes. 8. Fibular Plates The Fibular plates are available in 3-hole, 4-hole, 5-hole, 6-hole, 7-hole, 8- hole, 10-hole, and 12-hole versions. The Fibular Tubular plates are available 4-hole, 6-hole, 8-hole, 10-hole, and 12-hole versions. MATERIAL The implants included in the Integra TFS2 are manufactured from Ti-6Al-4V Titanium Alloy (ASTM F136). The instrumentation is manufactured from biocompatible materials. INDICATIONS FOR USE The Integra TFS2 is intended for skeletally mature patients for the following: Stabilization and fixation of fresh fractures. Intra and extra articular fractures, joint depression, and multi-fragmentary fractures. Revision procedures, joint fusion and reconstruction of small bones of the feet. CONTRAINDICATIONS Plates and screws are contraindicated in: active infection, conditions which tend to retard healing such as blood supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex, conditions that restrict the patient s ability or willingness to follow postoperative instructions during the healing process and foreign body sensitivity. Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. Foreign body sensitivity where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implementations. These implants are intended as a guide to normal healing, and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or non-unions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All

3 metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue. WARNINGS AND PRECAUTIONS No metallic surgical implant should be reused. Any metal implant, once used, should be discarded. Even though it appears undamaged, it may already have small defects and internal stress patterns which may lead to fatigue failure. Correct handling of the implant is extremely important. Avoid contouring metallic implants whenever possible. If necessary, or allowed by design, the device should not be bent sharply, reverse bent, notched or scratched. All of these operations can produce defects in the surface finish and internal stress concentrations, which may become the focal point for eventual failure of the appliance. If metal plates or other metallic devices are to be used together with the TFS2, all such devices should be manufactured from a metal that has a similar composition to avert possibility of galvanic corrosion or other metallic reactions. Correct selection of the implant is extremely important. The potential for success in fracture fixation is increased by the selection of the proper size, shape and design of the implants. The patient s anatomy and indication will determine the size of the TFS2 plate to be used. The size and shape of the human bones presents limiting restrictions on the size and strength of implants. Postoperative care is extremely important. The patient must be warned that noncompliance with postoperative instructions could lead to breakage of the implant requiring revision surgery to remove the device. The use of TFS2 provides the surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. The implants are intended as a guide to normal healing and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subject to repeated stress in use which can result in metal fatigue. Failure to immobilize a delayed union or nonunion of bone will result in excessive and repeated stresses which are transmitted by the body to any temporary internal fixation device prior to the healing of the fracture. Due to normal metal fatigue, these stresses can cause eventual bending or breakage of the device. Therefore, it is important that immobilization of the fracture site is maintained until firm bony union (confirmed by clinical and roentgenographic examination) is established.

4 No partial weight bearing or non-weight bearing device can be expected to withstand the unsupported stresses of full weight bearing. Until firm bone union is achieved, the patient should employ adequate external support and restrict physical activities which would place stress upon the implant or allow movement at the fracture site and delay healing. Detailed written instructions on the use and limitations of the device should be given to the patient. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending or breakage of the device are complications which may occur as a result of the weight bearing or muscle activity. An active patient or a debilitated or demented patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. While the surgeon must make the final decision on implant removal, whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished, particularly in younger more active patients. The MR environment presents risks to patients with metal implants. Review of the available literature documents that metal implants may heat resulting in tissue damage and may migrate out of position. They may also cause artifact affecting image quality. Physicians should take these risks into consideration when recommending MRI imaging for patients with metal implants. Note: Integra TFS2 has not been evaluated for safety and compatibility in the MR environment. The Integra TFS2 has not been tested for heating or migration in the MR environment. REPROCESSING INSTRUCTIONS The Integra TFS2 Instrument Tray and its contents are provided non-sterile, and must be cleaned and sterilized prior to use. All reusable instruments must be cleaned, inspected, and sterilized between uses. Always immediately clean and decontaminate all devices that have been soiled. Reusable instruments can be used indefinitely if not damaged, worn, or deteriorated, and should be inspected before each use for these conditions. DO NOT use broken, damaged, malfunctioning or deteriorated instruments. Examples of unacceptable wear or deterioration include any cracking, bending, corrosion, missing components, or visible wear which could impact function or performance (e.g. dull cutting edges). After cleaning the Ratchet Handle, a non-silicone lubricant should be used per the manufacturer s instructions for best results and to ensure proper working condition. Verify that all instruments required for use are present in the case. For manual cleaning, devices should be grouped according to similar metals before subsequent processing in order to prevent galvanic corrosion. In addition, it is not recommended to use chloride containing cleaning solutions since its use has been linked to corrosion of metallic instruments, especially stainless steel. Please also note the following: Disinfect and clean devices immediately after use in order to avoid device encrustations.

5 Solutions used for cleaning must always be prepared in accordance with the manufacturer s instructions. Never use metal brushes or metal sponges for manual cleaning. Use a suitably sized brush for cleaning lumens, cannulations, blind holes, and cavities, making sure that every part of the inner surface can be properly accessed. Clean jointed instruments in closed as well as open positions. Disassemble instruments as far as possible before cleaning. Be sure to arrange the items so that the water can easily flow out of cannulations, blind holes, and cavities. For instruments with long or narrow lumens, standard processing should be used only if the hot disinfectant can flow easily through the lumens and safe rinsing is guaranteed. The cases/trays used for cleaning must always be loaded correctly to ensure proper cleaning. After cleaning, check instruments for cleanliness (visible dirt). This especially applies to cannulated instruments or those with blind holes and crevices. To ensure proper instrument functioning, verify that all movable parts have been thoroughly cleaned. Pay special attention to slots, ratchets, joints and box locks, narrow lumens, blind holes, and other areas that are hard to access. Demineralized or distilled water should be used for the final rinse. MANUAL CLEANING INSTRUCTIONS The following steps should be completed in sequence: a) Prepare a neutral ph enzymatic detergent as per the manufacturer s recommendation (e.g. Enzol prepared at 1 oz. per gallon of lukewarm deionized water). b) Disassemble instruments to lowest level. c) Rinse instruments under lukewarm running water to remove all gross soil. Use a soft bristled brush to aid in the brushing. Agitate the instruments under the running water. Agitation includes actuating all movable parts such as opening and closing hinges and moving the instruments around under the running water. Use a clean soft bristled brush and/or pipe cleaner to brush and aid in the rinse for the exterior and interior of instruments. Use a syringe to flush any lumens. d) Fully immerse each device in the prepared detergent and allow it to soak for a minimum of two minutes. e) After soaking the devices, scrub them using a soft bristle brush and circular strokes to remove any visible soil. Pay particular attention to all the areas where the soil could be imbedded (i.e. grooves, crevices, lumens, blind holes). Use a syringe to flush lumens and a pipe cleaner to clean lumens and holes. Perform cleaning under the surface of the prepared detergent solution to limit aerosolization of the cleaning fluid and soil, as well as for worker and environmental safety. f) Rinse devices in lukewarm water for a minimum of one and a half (1.5) minutes to remove any detergent residuals. In accordance with Step C, agitate the instruments under the running water, being sure to actuate all movable parts, and using a soft bristled brush for internal and exterior device surfaces.

6 g) Prepare a neutral ph enzymatic detergent (eg. Enzol ) in a sonicator, as per the manufacturer s recommendation using lukewarm water. Fully immerse the devices in the detergent and sonicate for 10 minutes. h) After sonication, rinse the devices with running lukewarm water (use the highest grade of water available, distilled or deionized water is recommended) for three (3) minutes. Agitate the instruments under the running water, being sure to actuate all movable parts, and using a clean soft bristled brush for internal and exterior device surfaces, and flush all lumens with a syringe. i) Dry the devices using a clean lint free cloth and visually examine to determine if all adherent visible soil has been removed. j) Repeat the above cleaning procedure, if visible debris is detected. AUTOMATED IFU CLEANING PROCEDURE The following steps should be completed in sequence: a) Prepare an enzymatic detergent using lukewarm deionized water as per the manufacturer s recommendation. b) Fully immerse the devices and allow to soak for a minimum of two (2) minutes. c) Following the soak time, flush any lumens of the device using a syringe. d) Rinse the devices under lukewarm running deionized water for a minimum of one (1) minute, while agitating the devices. Agitation includes actuating all movable parts, such as opening and closing hinges and moving the devices around under the running water. e) Use a clean soft bristled brush and/or pipe cleaner to brush and aid in the rinse for the exterior and interior of device components. Use a syringe to flush any lumens. f) Place the devices back into the designated locations of the case/tray, and load the case/tray set into an automated washer (Steris 444 or equivalent). g) The washer cycle parameters are as follows: Phase Recirculation Time (Min.) Water Temperature Detergent Pre-Wash 1 02:00 Cold Water NA Enzyme Enzymatic 01:00 Hot Water Wash Cleaner Wash 1 02:00 60 C Neutral Detergent Rinse 1 10:00 Hot Water** NA **Note: The highest grade of water available should be used during the final rinse cycle. h) After washing, dry the devices using a clean lint free cloth and visually examine to determine if all adherent visible soil has been removed. i) Repeat the cleaning procedure if visible debris is detected.

7 INSPECTION AFTER CLEANING Following cleaning, the instruments must be macroscopically clean, i.e. free from visible dirt or deposits. All movable parts, working tips and blades (scissors) should be inspected with particular care. STERILITY The Integra TFS2 instrumentation are supplied non-sterile and must be sterilized before use. Do not reuse implants. They are single use only. Visually inspect the instruments under room lighting conditions to ensure instruments are suitable for use and free of debris. Sterilize with steam sterilization. The following cycles are recommended for wrapped goods: Cycle: Domestic EMEA Pre-vacuum Gravity Pre-vacuum Pre-vacuum Temperature: (274 F) 132 C (274 F) 132 C 134 C 134 C Exposure Time: 4 mins 15 mins 3 mins 18 mins Drying Time: 60 minutes 60 minutes 65 minutes 65 minutes ADVERSE EVENTS SURGICAL PROCEDURE Loosening, bending, cracking or fracture of the screw or loss of fixation in bone attributable to nonunion. Loss of anatomic position with nonunion or malunion with rotation or angulation. Infection, both deep and superficial. Allergies and other reaction to the device material. A Surgical Technique brochure is available which outlines the basic procedure for device implantation and the use of specialized surgical instrumentation. It is the responsibility of the surgeon to be familiar with the procedure before use of these products. Each surgeon must evaluate the appropriateness of the surgical technique used based on personal medical training and experience. Copies of the surgical technique may be obtained online at by contacting customer service at , or by contacting your local sales representative. TRAINING It is the responsibility of the surgeon to obtain the necessary training prior to implanting this implant. The surgeon should have specific training, experience, and thorough familiarity with the use of cannulated, non-cannulated, headless, and snap-off screws. The surgeon must exercise reasonable judgment when deciding which screw type to use for specific indications.

8 MANUFACTURED BY: Ascension Orthopedics Inc Cameron Road Austin, Texas USA Voice: Fax: AUTHORIZED REPRESENTATIVE: Integra LifeSciences Services France Immeuble Séquoia 2 97 Allée Alexandre Borodine Parc Technologique de la Porte des Alpes Saint Priest, France Voice +33 (0) Fax +33 (0)

9 Symbol Description Do not re-use Compliance with EU legislation Consult Instructions for use Manufacturer For prescription use only Implant plate and screw material is Ti-6AI-4V Titanium Alloy (ASTM F136) Reference Number Batch Number Authorized EC Representative in the European Community Quantity Non Sterile Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Enzol is a trademark of Johnson & Johnson Integra LifeSciences Corporation. All rights reserved. Printed in the USA. LC Rev A