Wrist Fixation System Instructions for Use

INSTRUCTIONS FOR USE TriMed® Wrist Fixation System for the International Community General: The TriMed® Bone Plates, Wire Forms, Pin Plates, and Screws are devices which are to be used as an aid to the treatment of certain types of fractures that lend themselves to the principle of plate and/or screw, wire form, or pin fixation, particularly those involving small fragments. Like every type of orthopaedic implant, it cannot be assumed to be uniformly effective without risk. Use of these implants is not a substitute for normal tissue healing. The TriMed Bone Plates, Wire Forms, Pin Plates, and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.

medical judgment if nickel allergy or hypersensitivity is suspected. 4. Skin atrophy. In the setting of profound skin atrophy, any internal fixation device should be approached with extreme caution because of the increased risk of wound healing problems and infection. Contraindications may be relative or absolute. Users of this device must carefully weigh the advantages against possible complications and consider the patient's entire clinical exam in addition to the items listed above.

Possible Adverse Effects:

Basic Design Features: The TriMed Bone Plates, Wire Forms, Pin Plates, and Screws are implants designed for fixation of certain fractures that are appropriate to the size, shape, and expected loads on these implants. Variation in implant size, diameter, and shape are intended to allow the implants to accommodate variations in patient size and sites of application. TriMed® Bone Plates, Wire Forms, Pin Plates, and Screws are manufactured from 316L medical grade implant quality stainless steel. TriMed Bone Plates, Wire Forms, and Pin Plates should only be used with TriMed Screws, Pegs, and Kwires.

Specific Design Features – TriMed Pin Plates: The Pin Plates are implants designed with holes at one end to accept appropriately sized bone screws, and openings for placement of TriMed K-wires at the other end. Each opening in the plate is designed to accept a screw or TriMed K-wire of specific dimensions; the surgeon must check to ensure that the appropriate-sized screw or K-wire is used for each opening. These plates should only be used with TriMed screws and K-wires.

In any surgical procedure, the potential for adverse reactions exists. Possible adverse effects particular to orthopaedic devices are listed below. These do not include all adverse effects which can occur with surgical procedures. 1. Loosening, bending, cracking or fracture of any component with or without loss of fixation in bone, possibly in association with osteoporosis, delayed union, nonunion, excess activity, or any of the factors listed previously. 2. Loss of anatomic position with resulting nonunion, malunion, or delayed union. 3. Infections. 4. Hematoma. 5. Stiffness of the adjacent joint with or without degenerative changes. 6. Tendinitis or tendon rupture. 7. Scarring. 8. Reflex sympathetic dystrophy. 9. Local bursitis and pain from prominent hardware. 10. Allergic responses to metal components are rare. These implants contain nickel, and as with any implant, they should be tested preoperatively if indicated.

Specific Design Features – TriMed Wire Forms: The TriMed Wire Forms are pre-contoured pins designed for fixation of certain fractures which are amenable to fixation with this type of implant; in general, these implants are used for small fragment fixation. The Wire Forms are designed to penetrate or buttress a small fragment from either the endosteal surface, periosteal surface, or both. These components are specially contoured pins which can be further bent as needed to provide maximal cortical apposition. TriMed® Wire Forms are secured to a stable cortical fragment using a TriMed 2.3mm bone screw and washer. TriMed Wire Forms should only be used with TriMed Screws and Washers. TriMed Sleds are a type of TriMed Wire Form in a pre-contoured design for use with fracture patterns that are appropriate and amenable to the technique of tension band wiring. The implants have an intraosseous portion consisting of two pins that are impacted longitudinally through predrilled holes across the fracture site; in addition, an extraosseous portion of the implant is placed in close apposition to the tension surface of the bone at the site of the fracture and secured in a position that applies compression to the bone fragments. The implants are secured to a stable cortical fragment using TriMed bone screws and washers that are designed for these implants.

Specific Design Features – TriMed Bone Plates and Screws: The TriMed Bone Plates, and Screws are general purpose plates used for fixation of fractures amenable to plate fixation. Variations in plate shapes, sizes, and screws including a range of configurations to provide specific hole and screw options that include non-locking, fixed angle locking and polyaxial locking screw fixation are provided. For example, the TriMed Bearing Plates offer a polyaxial locking mechanism at one end of the plate capable of directing a TriMed Screw or Peg anywhere within a continuous range of insertion angles but obtains angular locking and stability upon full insertion. The TriMed Peg Plates and Fixed Angle Plates provide locking screw and/or peg capability at a predetermined fixed angle. TriMed General Bone Plates provide screw holes designed to accommodate either non-locking or fixed angle locking screws. Although both fixed angle and polyaxial locking mechanism improve the resistance to angular movement, they are not designed to withstand unrestricted loads but rather to function as an aid to fracture healing. In this regard, the surgeon should take measures to avoid excessive forces on the implant until bone healing has taken place. This includes protection of the fracture when appropriate, and instructions to the patient to avoid excess loading of the extremity until sufficient healing has taken place.

Indications, Contraindications, Adverse Effects: Patient selection and sound surgical principles apply to the use of TriMed Bone Plates, Wire Forms, Pin Plates, and Screws in a given clinical setting. The device is appropriate for skeletally mature individuals. Specific fractures with configurations that lend themselves to the general principle of bone fixation with this class of implants may be appropriate for use with these devices. The decision to use an implant as well as the size and shape of the implant used must be based on sound medical judgment that takes into consideration factors such as the circumstances and configuration of the injury, and other clinical factors. As with orthopaedic surgery in general, the surgeon should take measures to avoid excessive force on implant until bone healing has taken place. This includes protection of the fracture when appropriate, and instructions to the patient to avoid excess loading of the extremity until sufficient healing has taken place. Medical personnel are encouraged to contact their TriMed representative(s) if a more comprehensive understanding of the implant, instrument(s) or system usability is required.

Specific Indications: The following fracture configurations may be applicable for treatment using TriMed® Bone Plates, Wire Forms, Pin Plates, and Screws: 1. Fractures of the distal radius or distal ulna. 2. Corrective osteotomies of the distal radius or distal ulna

Contraindications: 1. Physical conditions that would eliminate or tend to eliminate adequate implant support or retard healing, viz.: blood supply limitations, insufficient quality or quantity of bone, poor skin quality, previous infections, sepsis, etc. 2. Mental or neurologic conditions which tend to pre-empt the patient's ability or willingness to restrict activities during the healing period, viz.: Parkinson's disease, chronic alcoholism, Charcot's joints, drug abuse, mental illness or retardation, patien t noncompliance, etc. 3. Foreign body sensitivity. Where material sensitivity is suspected, standard appropriate tests should be made prior to material selection or implantation. In particular, the physician should be aware that stainless steel implant material contains nickel and should use sound

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The adverse effects listed here are not specific to the TriMed® Bone Plates, Wire Forms, Pin Plates, and Screws and can be observed with any implant. Promptly inform the TriMed Quality Department at quality@trimedortho.com if complications occur in connection with the implants or surgical instruments used. In the event of premature failure of an implant in which a causal relationship with its geometry, surface quality or mechanical stability is suspected, please provide TriMed with the device in a cleaned, disinfected and sterilized condition. TriMed cannot accept any other returns of used implants.

Warnings and Precautions: All TriMed Implants 1. TriMed implants are intended for single use only. Reuse of implant(s), that may be soiled by blood, tissue, and/or bodily fluids or matter, is prohibited. Violation of this could potentially result in loss of performance, function, fit or device failure, and could potentially result in infection. 2. TriMed implants are supplied in a non-sterile condition must be decontaminated and steam sterilized prior to surgical use. Prior to decontamination and/or sterilization, remove and dispose all original disposable packaging (e.g., pouches, bags, tubes, etc.) Disposable packaging is only for transient storage. Upon receipt, implants must be placed in sterilization tray. 3. Use caution in the handling and storage of implants. Cutting, bending, or scratching t he surface of metal components impairs the strength and fatigue life of the implant. Implants should be stored away from corrosive agents and environments. 4. Prior to implantation, inspect implants of any corrosion, discoloration, scratches, flaws, residue or debris, if found the device(s) should be discarded. 5. TriMed implants housed in polymer caddies, which have a limited lifespan, may be impacted by wear, damage or degradation of the caddy. Reference LC-73-0004-016, TriMed Reusable Surgical Instruments and Trays for details. 6. Implantation in patients with the contraindications specified previously should be avoided. It is important to preoperatively assess the radiographic configuration of the fracture, fusion or osteotomy prior to considering implantation of this device. In addition, all other relevant medical and social factors should be considered in order to determine whether a patient is an appropriate candidate for this device. 7. Allergies to component materials should be considered and tested, if appropriate, prior to using this device. See material composition under general regulatory information section. 8. A full inventory of instruments and implants should be available prior to initiation of the surgical procedure. Components should be tested in trial assembly prior to implantation. 9. Prior to performing surgery, surgeons are advised to review the product-specific surgical technique (https://trimedortho.com/surgical-techniques/). Surgeons should also be fully familiar with the biomechanics and surgical principles inherent to the use of this device, and proper selection and placement of the device are important considerations in successful utilization of this device. 10. Any adjacent soft tissue structures should be checked to ensure that abrasive rubbing against components will not occur. 11. Size and position of implants should be checked radiographically prior to completion of the surgical procedure. 12. Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress. The fixation provided by this device should be protected. The postoperative protocol prescribed by the surgeon should be strictly followed to avoid adverse conditions applied or subject to the device. 13. TriMed Bone Plates with terminal ends (e.g., hooks, tines, legs) must be inserted and/or impacted into bone coaxial to the pre-drilled holes. Excessive or improper insertion angle can potentially deform or adversely affect the strength and fatigue life of the implant. 14. TriMed Screws should be inserted by hand, and are not advised to be placed under powered equipment. Possible risks using screws under power include stripping, bending, cracking or fracturing of the implant and/or instrument. 15. TriMed Bone Plates, Wire Forms, and Pin Plates should only be used with the appropriate size TriMed Pins, Bone Screws, Pegs and Washers. TriMed has not tested compatibility with devices provided by other manufacturers and assumes no liability in such instances . 16. Removal of TriMed Pin Plates, Bone Plates, Wire Forms, Washers, Pegs, and/or Screws may be warranted if deemed medically necessary in order to avoid possible adverse effects. Temporary joint spanning plates, such as bridge plates, must be periodically monitored and removed once bone healing has occurred. 17. Explanted or soiled device(s) should be placed in medical waste disposal containers and disposed of according to the facility procedures and required compliance regulations.

18. These devices have not been evaluated for safety and compatibility in the MR environment. The devices have not been tested for heating, migration or image artifact in the MR environment. During MR safety screening, medical staff should brief patients implanted

Doc. No.: LC-73-2004-005-ENG

This document is uncontrolled if downloaded or printed. For the latest controlled revision refer to www.trimedortho.com/ifu

Rev. 2.0 (Feb-22)