WRIGHT Medical

Mini MaxLock Extreme Instructions for Use

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Mini MAXLOCK EXTREME™ SYSTEM Instructions for Use 1) DEVICE DESCRIPTION a) The Mini MaxLock ExtremeTM Plating System consists of various sizes of plates and screws used to stabilize and aid in the fusion or repair of fractured small bones. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable metal components are made from Ti-6AL-4V ELI Titanium Alloy per ASTM F-136. All implantable polymer components are made from Invibio PEEK OPTIMA® (PEEK) per ASTM F-2026. 2) INDICATIONS FOR USE a) The Mini MaxLock ExtremeTM Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. b) The Mini Variable System, when used with the Mini MaxLock ExtremeTM Plating System, is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. 3) CONTRAINDICATIONS a) Cases where there is an active infection. b) Cases with malignant primary or metastasis tumors, which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. c) Conditions which tend to retard healing, such as, blood supply limitations, previous infections, etc. d) Insufficient quantity or quality of bone to permit stabilization of the fracture complex. e) Conditions that restrict the patient’s ability or willingness to follow post-operative instructions during the healing process. f) Foreign body sensitivity – where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. g) Cases where the patient is obese. 4) DIRECTIONS FOR USE a) An appropriately sized plate is chosen and placed such that the screw holes span the fracture, fusion, or osteotomy site. While it is okay to have some screw holes positioned over that site, the plate should be fixed to the bone via screws on both sides. Note that when using plates with center holes, they may be placed on either side of the fracture site. b) The correctly sized drill bit and guide sleeve are utilized to produce holes for the screw to be inserted. Locking drill guides must be used when inserting a fixed angle locking screw so that the drill angle is correct. c) Screws are inserted with care to ensure that the threaded portion of the screw does not span the implant/bone interface or a fracture surface. When screws are used for adjuvant fixation with bone cement, the screws must be inserted while the cement is in the doughy stage for optimal results. Additionally, when used in this application, the screw heads must be fully seated into the recess of the plate when tightened. d) Detailed surgical techniques for implantations are available. 5) WARNINGS AND PRECAUTIONS a) Screws are not intended for use in the pedicles of the spine. b) Surgical technique and training i) Read all instructions carefully. Failure to follow the instructions, warnings, and precautions may lead to serious surgical consequences or injury to the patient. ii) NO SURGICAL IMPLANT SHOULD BE REUSED. Any 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. iii) Preoperative and operative procedures, including knowledge of surgical technique, stable anatomic reduction and proper selection and placement of the implants are important considerations in the successful utilization of temporary internal fixation devices. See the surgical technique for specific surgical procedures. MXM-800-001 Rev 8 iv) CORRECT HANDLING OF IMPLANTS IS EXTREMELY IMPORTANT. Avoid WEIGHT BEARING. Until firm bone union is achieved, the patient should employ contouring metallic plates whenever possible. If contouring is necessary, the plate adequate external support and restrict physical activities which would place stress should not be bent sharply, reverse bent, notched or scratched. All of these upon the implant or allow movement at the fracture site and delay healing. operations can produce defects in the surface finish and internal stress v) Detailed written instructions on the use and limitations of the device should be given concentrations, which may become the focal point for eventual failure of the device. to the patient. If partial weight bearing is recommended or required prior to fusion, Do not bend screws. the patient must be warned that bending or breakage of the device are complications v) If bending a plate through a threaded locking hole, the utilization of non-locking which may occur as a result of the weight bearing or muscle activity. An active, screws is recommended to insert through those particular holes, as the amount of debilitated or demented patient who cannot properly utilize weight support devices deformation may inhibit threaded screws from fully seating due to deformation may be particularly at risk during postoperative rehabilitation. incurred. g) Removal of the Device vi) If metal screws, wire bands, or other metallic devices are to be used together with i) While the surgeon must make the final decision on implant removal, whenever the plates, all such devices should be manufactured from a metal that has a similar possible and practical for the individual patient, fixation devices should be removed composition to avert possibility of galvanic corrosion or other metallic reactions. once their service as an aid to healing is accomplished, particularly in younger and c) Implant Sizing more active patients. i) CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. h) Disposal of the Device The potential for success in fracture fixation is increased by the selection of the i) Upon removal of implant(s), dispose of as a biohazard material. proper size, shape, and design of the implants. The patient’s anatomy will determine i) Magnetic Resonance Imaging (MRI) Safety and Compatibility the size of the plate and screws to be used. The size and shape of the anatomy i) The Mini MaxLock ExtremeTM Plating System implants may affect image quality (image artifact) depending on the pulse sequence that is used for MR imaging. presents limiting restrictions on the size and strength of the implants. ii) This product has not been evaluated for safety and compatibility in the MR ii) The Mini MaxLock ExtremeTM implants are designed for smaller anatomies. For TM larger anatomies or higher load applications consider using the MaxLock Extreme environment. It has not been tested for heating, migration, or image artifact in the System. MR environment. The safety of this product in the MR environment is unknown. d) Patient Selection Scanning a patient who has this device may result in patient injury. i) When evaluating patients for orthopedic device application, the patient’s weight, The Mini MaxLock Extreme® Plating System has not been tested for heating or migration in the MR environment. occupation, activity level, and any degenerative diseases are of extreme importance to the eventual success of the procedure. These conditions must be evaluated as part 6) POSSIBLE ADVERSE AFFECTS of the preoperative planning. Conditions of senility, mental illness, alcoholism, a) Loosening, bending, cracking or fracture of the plate, or loss of fixation in bone tobacco, or drug abuse must also be taken into consideration. attributable to nonunion, osteoporosis, or markedly unstable comminuted fractures. ii) Final treatment decision is at the discretion of the physician and patient. b) Loss of anatomic position with nonunion or malunion with rotation or angulation. e) Device Compatibility c) Infection, both deep and superficial. i) It is not recommended to use other manufacturer’s implants in any assembly or d) Allergies and other reaction to the device material. construct application in conjunction with these implants. 7) CLEANING AND STORAGE TM ii) The Mini MaxLock Extreme implants are not compatible with the MaxLock a) Store in a cool, dry place. ExtremeTM implants. b) The Mini MaxLock ExtremeTM Plating System instruments are provided non-sterile and f) Post-Operative Care must be cleaned before use. i) NOTE: Postoperative care is extremely important. The patient must be warned that i) Completely disassemble instruments, as appropriate. noncompliance with postoperative instructions could lead to breakage of the implant ii) Rinse instruments in lukewarm tap water until all visible soil is removed. requiring revision surgery to remove the device. iii) Fully immerse instruments in enzymatic detergent for a minimum of 10 minutes. ii) The use of plates provides the orthopedic surgeon a means of bone fixation and helps Thoroughly brush the instruments using a soft-bristled brush, assuring all hard to generally in the management of fractures and reconstructive surgeries. These reach areas and cannulas are accessed. A syringe or pipe cleaner may be used if implants are intended as a guide to normal healing and are NOT intended to replace applicable. normal body structure or bear the weight of the body in the presence of incomplete iv) Rinse instruments in lukewarm tap water until all detergent residues are removed. bone healing. Delayed unions or nonunions in the presence of load bearing or weight v) Fully immerse instruments in a neutral pH (7.0) or mild detergent. Thoroughly bearing might eventually cause the implant to break due to metal fatigue. All metal brush the instruments using a soft-bristled brush, assuring all hard to reach areas and surgical implants are subject to repeated stress in use which can result in metal cannulas are accessed. failure. vi) Rinse instruments in lukewarm tap water until all detergent residues are removed. iii) Failure to immobilize a delayed union or nonunion of bone will result in excessive vii) Visually inspect the instruments to ensure instruments are suitable for use and free and repeated stresses which are transmitted by the body to any temporary internal of debris prior to sterilization. fixation device prior to the healing of the fracture. Due to normal metal fatigue, these 8) STERILIZATION stresses can cause eventual bending or breakage of the device. Therefore, it is a) The Mini MaxLock ExtremeTM Plating System implants and instruments are supplied important that immobilization of the fractures site is maintained until firm bony non-sterile and must be sterilized before use. union (confirmed by clinical and roentgenographic examination) is established. i) Do not reuse implants; they are one-time use only. iv) NO PARTIAL WEIGHT BEARING OR NONWEIGHT BEARING DEVICE CAN ii) Do not use the device if damage is present such as nicks, gouges, or scratches. BE EXPECTED TO WITHSTAND THE UNSUPPORTED STRESSES OF FULL 10801 Nesbitt Avenue South, Bloomington, MN 55437 Phone: 952-921-7100 Fax: 952-236-4007 "Caution: Federal law restricts this device to sale by or on the order of a physician". Various aspects of the Mini MaxLock Extreme™ System including the plates, screws, instruments, and the design method are covered by multiple patents pending or issued patents in the United States and other jurisdictions. ©2016 Wright Medical Group N.V., or its affiliates. All Rights Reserved.

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Mini MAXLOCK EXTREME™ SYSTEM Instructions for Use 1) DEVICE DESCRIPTION a) The Mini MaxLock ExtremeTM Plating System consists of various sizes of plates and screws used to stabilize and aid in the fusion or repair of fractured small bones. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable metal components are made from Ti-6AL-4V ELI Titanium Alloy per ASTM F-136. All implantable polymer components are made from Invibio PEEK OPTIMA® (PEEK) per ASTM F-2026.

2) INDICATIONS FOR USE a) The Mini MaxLock ExtremeTM Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. b) The Mini Variable System, when used with the Mini MaxLock ExtremeTM Plating System, is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

3) CONTRAINDICATIONS a) Cases where there is an active infection. b) Cases with malignant primary or metastasis tumors, which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. c) Conditions which tend to retard healing, such as, blood supply limitations, previous infections, etc. d) Insufficient quantity or quality of bone to permit stabilization of the fracture complex. e) Conditions that restrict the patient’s ability or willingness to follow post-operative instructions during the healing process. f) Foreign body sensitivity – where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. g) Cases where the patient is obese.

4) DIRECTIONS FOR USE a) An appropriately sized plate is chosen and placed such that the screw holes span the fracture, fusion, or osteotomy site. While it is okay to have some screw holes positioned over that site, the plate should be fixed to the bone via screws on both sides. Note that when using plates with center holes, they may be placed on either side of the fracture site. b) The correctly sized drill bit and guide sleeve are utilized to produce holes for the screw to be inserted. Locking drill guides must be used when inserting a fixed angle locking screw so that the drill angle is correct. c) Screws are inserted with care to ensure that the threaded portion of the screw does not span the implant/bone interface or a fracture surface. When screws are used for adjuvant fixation with bone cement, the screws must be inserted while the cement is in the doughy stage for optimal results. Additionally, when used in this application, the screw heads must be fully seated into the recess of the plate when tightened. d) Detailed surgical techniques for implantations are available.

5) WARNINGS AND PRECAUTIONS a) Screws are not intended for use in the pedicles of the spine. b) Surgical technique and training i) Read all instructions carefully. Failure to follow the instructions, warnings, and precautions may lead to serious surgical consequences or injury to the patient. ii) NO SURGICAL IMPLANT SHOULD BE REUSED. Any 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. iii) Preoperative and operative procedures, including knowledge of surgical technique, stable anatomic reduction and proper selection and placement of the implants are important considerations in the successful utilization of temporary internal fixation devices. See the surgical technique for specific surgical procedures.

MXM-800-001 Rev 8

iv) CORRECT HANDLING OF IMPLANTS IS EXTREMELY IMPORTANT. Avoid WEIGHT BEARING. Until firm bone union is achieved, the patient should employ contouring metallic plates whenever possible. If contouring is necessary, the plate adequate external support and restrict physical activities which would place stress should not be bent sharply, reverse bent, notched or scratched. All of these upon the implant or allow movement at the fracture site and delay healing. operations can produce defects in the surface finish and internal stress v) Detailed written instructions on the use and limitations of the device should be given concentrations, which may become the focal point for eventual failure of the device. to the patient. If partial weight bearing is recommended or required prior to fusion, Do not bend screws. the patient must be warned that bending or breakage of the device are complications v) If bending a plate through a threaded locking hole, the utilization of non-locking which may occur as a result of the weight bearing or muscle activity. An active, screws is recommended to insert through those particular holes, as the amount of debilitated or demented patient who cannot properly utilize weight support devices deformation may inhibit threaded screws from fully seating due to deformation may be particularly at risk during postoperative rehabilitation. incurred. g) Removal of the Device vi) If metal screws, wire bands, or other metallic devices are to be used together with i) While the surgeon must make the final decision on implant removal, whenever the plates, all such devices should be manufactured from a metal that has a similar possible and practical for the individual patient, fixation devices should be removed composition to avert possibility of galvanic corrosion or other metallic reactions. once their service as an aid to healing is accomplished, particularly in younger and c) Implant Sizing more active patients. i) CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. h) Disposal of the Device The potential for success in fracture fixation is increased by the selection of the i) Upon removal of implant(s), dispose of as a biohazard material. proper size, shape, and design of the implants. The patient’s anatomy will determine i) Magnetic Resonance Imaging (MRI) Safety and Compatibility the size of the plate and screws to be used. The size and shape of the anatomy i) The Mini MaxLock ExtremeTM Plating System implants may affect image quality (image artifact) depending on the pulse sequence that is used for MR imaging. presents limiting restrictions on the size and strength of the implants. ii) This product has not been evaluated for safety and compatibility in the MR ii) The Mini MaxLock ExtremeTM implants are designed for smaller anatomies. For TM larger anatomies or higher load applications consider using the MaxLock Extreme environment. It has not been tested for heating, migration, or image artifact in the System. MR environment. The safety of this product in the MR environment is unknown. d) Patient Selection Scanning a patient who has this device may result in patient injury. i) When evaluating patients for orthopedic device application, the patient’s weight, The Mini MaxLock Extreme® Plating System has not been tested for heating or migration in the MR environment. occupation, activity level, and any degenerative diseases are of extreme importance to the eventual success of the procedure. These conditions must be evaluated as part 6) POSSIBLE ADVERSE AFFECTS of the preoperative planning. Conditions of senility, mental illness, alcoholism, a) Loosening, bending, cracking or fracture of the plate, or loss of fixation in bone tobacco, or drug abuse must also be taken into consideration. attributable to nonunion, osteoporosis, or markedly unstable comminuted fractures. ii) Final treatment decision is at the discretion of the physician and patient. b) Loss of anatomic position with nonunion or malunion with rotation or angulation. e) Device Compatibility c) Infection, both deep and superficial. i) It is not recommended to use other manufacturer’s implants in any assembly or d) Allergies and other reaction to the device material. construct application in conjunction with these implants. 7) CLEANING AND STORAGE TM ii) The Mini MaxLock Extreme implants are not compatible with the MaxLock a) Store in a cool, dry place. ExtremeTM implants. b) The Mini MaxLock ExtremeTM Plating System instruments are provided non-sterile and f) Post-Operative Care must be cleaned before use. i) NOTE: Postoperative care is extremely important. The patient must be warned that i) Completely disassemble instruments, as appropriate. noncompliance with postoperative instructions could lead to breakage of the implant ii) Rinse instruments in lukewarm tap water until all visible soil is removed. requiring revision surgery to remove the device. iii) Fully immerse instruments in enzymatic detergent for a minimum of 10 minutes. ii) The use of plates provides the orthopedic surgeon a means of bone fixation and helps Thoroughly brush the instruments using a soft-bristled brush, assuring all hard to generally in the management of fractures and reconstructive surgeries. These reach areas and cannulas are accessed. A syringe or pipe cleaner may be used if implants are intended as a guide to normal healing and are NOT intended to replace applicable. normal body structure or bear the weight of the body in the presence of incomplete iv) Rinse instruments in lukewarm tap water until all detergent residues are removed. bone healing. Delayed unions or nonunions in the presence of load bearing or weight v) Fully immerse instruments in a neutral pH (7.0) or mild detergent. Thoroughly bearing might eventually cause the implant to break due to metal fatigue. All metal brush the instruments using a soft-bristled brush, assuring all hard to reach areas and surgical implants are subject to repeated stress in use which can result in metal cannulas are accessed. failure. vi) Rinse instruments in lukewarm tap water until all detergent residues are removed. iii) Failure to immobilize a delayed union or nonunion of bone will result in excessive vii) Visually inspect the instruments to ensure instruments are suitable for use and free and repeated stresses which are transmitted by the body to any temporary internal of debris prior to sterilization. fixation device prior to the healing of the fracture. Due to normal metal fatigue, these 8) STERILIZATION stresses can cause eventual bending or breakage of the device. Therefore, it is a) The Mini MaxLock ExtremeTM Plating System implants and instruments are supplied important that immobilization of the fractures site is maintained until firm bony non-sterile and must be sterilized before use. union (confirmed by clinical and roentgenographic examination) is established. i) Do not reuse implants; they are one-time use only. iv) NO PARTIAL WEIGHT BEARING OR NONWEIGHT BEARING DEVICE CAN ii) Do not use the device if damage is present such as nicks, gouges, or scratches. BE EXPECTED TO WITHSTAND THE UNSUPPORTED STRESSES OF FULL

10801 Nesbitt Avenue South, Bloomington, MN 55437 Phone: 952-921-7100 Fax: 952-236-4007 "Caution: Federal law restricts this device to sale by or on the order of a physician". Various aspects of the Mini MaxLock Extreme™ System including the plates, screws, instruments, and the design method are covered by multiple patents pending or issued patents in the United States and other jurisdictions. ©2016 Wright Medical Group N.V., or its affiliates. All Rights Reserved.

Mini MAXLOCK EXTREME™ SYSTEM Instructions for Use b) Sterilize with steam sterilization. The following steam sterilization cycle is recommended based upon validation of a single Mini MaxLock ExtremeTM Plating System tray with an FDA cleared sterilization wrap and an FDA cleared steam sterilizer using strips and sutures. Flash sterilization is NOT recommended, but if used, should only be performed according to requirements of ANSI/AAMI ST79: 2006 – Comprehensive guide to steam sterilization and sterility assurance in health care 8) STERILIZATION (cont.) b) (cont.) facilities. Sterilization cycles beyond the prescribed parameters must be validated independently by the facility. Each facility’s process parameters should be validated for the type of sterilization equipment and product load configuration. (1) Recommended cycle: four minutes in a 270°F (132°C) pre-vacuum steam sterilization. (2) Recommended dry time: sixty minutes. ii) If the Mini MTP Caddy is included in the case and tray, remove the silicone mat from the utility bin and open up the ratchet on the stagbeetle forceps (MXM-062). See image below.

Open up ratchet on stagbeetle forceps (MXM062).

9) LOANER AND CONSIGNMENT SET SHIPMENTS b) All instruments and implants must be placed back in their respective trays within their appropriate sterilization case and sterilized per the sterilization instructions above prior to shipping back to the manufacturer. Any implants or instrumentation damaged due to neglect from mishandling or mispackaging will be billed to the customer.

10) RATCHETING HANDLE CARE b) The following guidelines are intended to provide care and handling instructions for stainless steel ratcheting drivers. These guidelines are not intended for use with electrical, pneumatic or powered surgical instruments. c) All instruments are shipped in a NON-STERILE condition and MUST be cleaned, lubricated, and autoclaved prior to use. d) CLEANING i) MANUAL CLEANING (1) Clean instruments as quickly as possible after each use. It is important not to allow blood or debris to dry on the instruments. If cleaning must be delayed, store the ratcheting driver in a covered container with the appropriate detergent or cleaning solution to delay drying. Do not use high concentrations of chlorine bleach on stainless steel instruments or pitting will occur. Do not use abrasive pads or cleansers. This will scratch the surface of the driver and remove the protective coating. This can lead to corrosion, dirt collection, and water deposits. Sort instruments by similar metal for subsequent processing to avoid electrolytic deposition (galvanic corrosion) due to contact between dissimilar metals. ii) ULTRASONIC CLEANING (1) Ultrasonic cleaners are effective when used per the manufacturer’s instructions with specially formulated detergents. It is recommended that all visible blood and debris be removed from the instrument prior to ultrasonic cleaning. Sort instruments by similar metal for subsequent processing to avoid electrolytic deposition (galvanic corrosion) due to contact between dissimilar metals.

MXM-800-001 Rev 8

g) RINSING THE DRIVER i) Avoid using tap water for rinsing the driver. The minerals in tap water can cause driver discoloration or staining. Use demineralized water for rinsing in order to prevent spotting. If tap water must be used for the final rinsing, dry the instruments immediately to prevent staining. h) MAINTAINING CORROSION RESISTANCE The ratcheting drivers are made of corrosion resistant specialty stainless steels. These steels form a passive oxide layer on the driver surface to protect them against corrosion. In order to maintain the quality of this protective layer, it is imperative to use and maintain the ratcheting driver properly. Failure to follow the provided instructions can lead to rust formation, which reduces the life of the instrument and the corrosion resistance. i) CALIBRATING TORQUE LIMITING HANDLE i) Calibration cycles are dependent on product handling and the frequency of use. It is recommended to return the product for torque verification or adjustment after one of the following are met: (1) Six months of use (2) 200 autoclave cycles (3) Approximately 3000 actuations (Clicks) j) IF AT ANY TIME A DEVICE SEEMS TO BE MALFUNCTIONING, REMOVE IT FROM SERVICE IMMEDIATELY AND RETURN FOR RECALIBRATION OR REPLACEMENT k) These guidelines are written to provide general information on the care and cleaning of surgical instruments. Attention has been paid to chemical and corrosion contacts that may inadvertently degrade, corrode, or otherwise shorten the expected life of hand held surgical instruments. These guidelines are not all-inclusive and do not outline every possible chemical contact or reaction that may occur while handling or cleaning.

Remove silicone mat from utility bin.

e) LUBRICATION i) Ultrasonic cleaning effectively removes all lubricant, so it is important to relubricate each driver immediately after cleaning. The use of an antibacterial, lubricating rust inhibitor is highly recommended. This water-soluble lubricant should be mixed in a bath solution made with demineralized water. Instruments should be immersed in this solution for 30 seconds and allowed to drip dry. This allows for the formation of a lubricant film that will remain throughout the sterilization process and this film will continue to protect the drivers during storage. This process guards instruments from staining and corrosion during sterilization and storage. f) AUTOCLAVING i) Staining and spotting may result if residual chemicals are not completely rinsed from instruments prior to steam sterilization. It is imperative to follow the proper sterilization and drying cycles outlined in the enclosed equipment literature. Failure to follow the provided instructions may result in incomplete sterilization, excess moisture formation, and water spotting.

Manufacturer: TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437 USA Tel: (952) 921-7100 Fax: (952) 236-4007

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