VariAx Hand Instructions for Use

V15366 Rev AA, 10-2021

CONTENTS

1 2 3 4 5 6 7

Description and Material Intended Purpose Indications Contraindications Intended Users Patient Target Group Warnings and Precautions

3 3 3 4 4 4 5

8 9 10 11 12 13

Magnetic Resonance Imaging (MRI) Information Informing the Patient Clinical Benefits Performance Characteristics Adverse Events and Adverse Effects Sterility, Cleaning and Sterilization 13.1 Devices Delivered Sterile 13.2 Devices Delivered Unsterile or being Resterilized

7 8 8 8 9 9

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14 15 16 17 18

Notification Transport and Storage Information Special Training For Further Information Disposal

10 10 11 11 11

7.1 7.2

Pre-Operative Intra-Operative

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VariAx® Hand ALL OF THESE INSTRUCTIONS FOR USE MUST BE READ CAREFULLY PRIOR TO CLINICAL USE 1 Description and Material The VariAx Hand implants include non-locking plates and screws, and locking plates.

The components of the VariAx Hand implants are composed of the following materials: Component Non-locking plates Screws

Material Titanium grade 4 / 3.7065 or Ti6Al4V / 3.7165 commercially pure titanium

According to Standard ASTM F67 and ISO 5832-2 or ASTM F136 ASTM F67

Locking plates

commercially pure titanium

ASTM F67

(Titanium Grade 4 / 3.7065) (Titanium Grade 2 / 3.7035)

2 Intended Purpose The devices are non-active implants intended to provide temporary stabilization for bones or bone fragments. 3 Indications The VariAx Hand implants are indicated for internal fixation of the bones of the hand for the following procedures: • fracture fixation • arthrodesis • deformity correction • reconstruction

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4 Contraindications The licensed healthcare professional’s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment. They should warn patients about these contraindications and limitations when appropriate.

Conditions presenting an increased risk of failure include: • Any active or suspected latent infection or marked local inflammation in or about the affected area. • Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site. • Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices. • Material sensitivity, documented or suspected. • Patients having inadequate tissue coverage over the operative site. • Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care. • Other medical or surgical conditions which would preclude the potential benefit of surgery. 5 Intended Users The VariAx Hand implants are intended to be used by licensed healthcare professionals. The healthcare professionals should be fully aware of the intended use of the products and the applicable surgical techniques and should be qualified by appropriate training methods (for example, relevant surgical residency programs). Additional user groups include nurses and reprocessing staff in handling, cleaning, and sterilization of the devices, where applicable. 6 Patient Target Group The target group for the application of the implants is skeletally mature patients. The application of all implants is according to the judgment of the licensed healthcare professional with utilization at the appropriate anatomical structures as defined in the indications.

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7 Warnings and Precautions Always consult the relevant operative techniques for additional information regarding each operative step. • Responsibility for proper selection of patients, adequate training, experience in the choice and placement of implants and the decision to leave or remove implants postoperatively, rests with the surgeon. • VariAx Hand implants are not designed to bridge bony gaps. Application of such may lead to premature implant failure. • The correct selection of the product is extremely important. The product should be used in the correct anatomic location, consistent with accepted standards for internal fixation. Failure to use the appropriate product for the application may result in a premature clinical failure. Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, or fracturing of the product and/or bone. • Single use devices cannot be reused, as they are not designed to perform as intended after the first usage. Mechanical, physical or chemical properties of single use device may be compromised after first usage. In this case, the safety and performance of the devices are not supported by the manufacturer, compliance to relevant specifications cannot be ensured. • The licensed healthcare professional and operating room team must be thoroughly familiar with the operating technique, the instruments, as well as the range of implants to be applied. Complete information and labeling on these subjects must be readily available at the workplace. • Screw and plate implants are designed to function only until normal bone healing is completed (usually 6 –12 weeks). Delayed healing, non-union, bone resorption or additional trauma may lead to excessive stress on the implant(s) and result in loosening, bending, cracking or breaking of the implant(s).

• Do not use components of Stryker product systems in conjunction with components from any other manufacturer’s system unless otherwise specified (see operative technique). • Prior to implant explantation, the screw head recess should be cleaned of debris by means of a scalpel or other instrument to provide an optimal fit between blade and screw. It is also recommended to use the Grasping Sleeve for explantation.

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7.1 Pre-Operative • Careful handling and storage of the product is required. Scratching or damage to the implants can significantly reduce the strength and fatigue resistance of the product. • Inspection is recommended prior to surgery to determine if implants and instruments have been damaged during storage. • Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other. • It is recommended to use a depth gauge before selecting the length of the screw. 7.2 Intra-Operative • Contouring or bending of an implant should be avoided where possible, because it may reduce the strength and can cause failure under load. If contouring is necessary for anatomical reasons, sharp bends, reverse bends, or bending the device over a screw hole (incl. elongated screw holes) must be avoided or the implant must be discarded. Also, if a locking hole is deformed during bending, the locking mechanism is prone to failure. It is essential to ensure that the desired shape is reached in as few bends as possible. All bending actions have to be performed with Stryker bending instruments and in accordance with specific procedures, if applicable. • Particles should be removed to prevent potential inflammation. • Each VariAx bone and/or locking screw should be additionally tightened upon completion of implantation to verify a rigid connection between the screw and plate. • Fracture treatment should be performed with a minimum of six cortices with nonlocking per side, or preferably at least 4 cortices with locking screws. • Never use a combination of different implant materials for permanent fixation except intraoperatively e.g. stainless steel k-wires together with titanium plates. • For explantation, remain in the axis of the screw to avoid screw head failures.

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• It is particularly important to regularly screen with an image intensifier when using drilling instrumentation, and during the placement of the implants. In all cases, the benefit of fluoroscopy should be weighed against the risk from radiation exposure on an individual patient basis, in the line with requirements of SI2000 No.1059 (The Ionising Radiation Regulations – Medical Exposure). • 1.7 mm S locking plates are not to be used for adult metacarpal bones. • Plates should be contoured anatomically to bone as closely as possible. • Use cross-pin screwdriver blade with or without the grasping sleeve for the VariAx Hand implants. • When loading the screw, align the cross-pin screwdriver blade to the cross-pin screw head. Keep the screwdriver perpendicular to the screw head and apply some moderate downward pressure, an audible “Click” should be heard. To remove the cross-pin screwdriver blade from the cross-pin screw, rock the screwdriver handle back and forth at a 45 degree angle to help loosen the blade and screw engagement. • If using a grasping sleeve: Please be sure to load the screw properly. After loading the screw, slide the tension sheath carefully forward (towards the screw) to the close the tension pliers and encompass the screw carefully. • Placement of all screws requires the use of the drill guide to ensure proper screw placement. If a drill guide is not used for locking screws, the screw may not lock into the plate. • The angle of the inserted VariAx locking screw must not exceed 10° with the use of the VariAx Hand plates. • Locking screws may not lock properly into the plate´s adaptation hole. Therefore we recommend using regular bone screws. • When engaging a screwdriver blade within a screw head, the blade must be fully seated within the head of the screw. This results in proper axial alignment and full contact between driver and screw, minimizing the risk of damage and leading to optimal friction fit performance. • Screws should not be over-tightened during insertion. Excessive over-tightening will compromise the integrity of the screw head result in possible screw breakage, and may lead to stripping of the locking threads result in loss of friction fit performance. In the event that a locking screw thread strips out, a bone screw should be used. • Excessive tightening of the locking screw may lead to titanium particle generation. 8

Magnetic Resonance Imaging (MRI) Information

VariAx Hand implants have not been evaluated for safety and compatibility in the Magnetic Resonance (MR) environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the VariAx Hand implants in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

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9

Informing the Patient • Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time. • The implant is intended for temporary bone fixation. In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example breakage or loosening of the implant or instability of the implant system. The patient is made aware to inform his/her physician in order to carry out follow-up examinations of the implants at regular intervals.

The implantation affects the patient’s ability to carry loads and her/his mobility and general living circumstances. For this reason, the licensed healthcare professional must counsel each patient individually on correct behavior and activity after the implantation. The licensed healthcare professional must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future. Explain also the need to appear for the postoperative examinations (e.g. X-ray checks) and for the possible explantation of the implant. 10 Clinical Benefits The VariAx Hand implants are intended to provide temporary stabilization of bones and bone fragments to support bone consolidation or fusion. 11 Performance Characteristics When used according to the manufacturer’s instructions for use and labelling, the implants are intended to support bone consolidation by providing temporary stabilization of bones and bone fragments until bone consolidation has been achieved.

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12 Adverse Events and Adverse Effects Complications that may occur as a result of internal fixation of bones of the hand with plates and/or screws include: Loss of range of motion, delayed union, pain/implant pain, tactile disorders, impaired healing, complex regional pain syndrome (CRPS), deformity/disfigurement (fingernail), nerve damage, non-union bone fracture, adhesion(s), malunion, infection/post-operative wound infection, necrosis (metacarpal head), muscle weakness, swelling/edema, increased sensitivity (to cold), itching sensation, scar tissue, hypersensitivity/allergic reaction, bone/joint damage, iatrogenic fracture, motor loss, pulmonary embolism, sensory loss, other soft tissue damage, and thrombosis. Device failure modes for hand plates and screws may include implant breakage, loosening, migration, and material deformation/bending. In some cases, adverse effects associated with plate and/or screw fixation may result in the need for additional or revision surgery. 13 Sterility, Cleaning and Sterilization • Products not labelled as sterile are non-sterile. • The packaging of all sterile products should be inspected before opening. In the presence of flaws, if the packaging was unintentionally opened before use or expiration of shelf life, the product must be assumed non-sterile. • In the event of contamination, or expiration of shelf life or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides. • For adequate cleaning of multi-component instruments, these must be dismantled according to the assembly/disassembly instructions provided by Stryker. • Please note that Stryker trays are intended for sterilization, transport and storage of medical devices. They are not designed for cleaning and disinfection in the fully equipped state. The devices must be removed from the tray for adequate cleaning results. For further information, please refer to the “Instructions for Cleaning, Sterilization, Inspection and Maintenance” (OT-RG-1). Operative techniques and cleaning instructions (OT-RG-1) may be requested online at www.stryker.com. 13.1 Devices Delivered Sterile Products delivered sterile have been exposed to a minimum of 25 kGy of gamma radiation from a cobalt 60 source. Visually inspect all sterile barrier systems for breaches of packaging integrity immediately prior to use.

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13.2 Devices Delivered Unsterile or being Resterilized The following process parameters are validated by Stryker and recommended for sterilization and/or resterilization, but not suitable for prion inactivation though: Method: Moist heat sterilization according to EN ISO 17665 Cycle: Saturated steam with fractional forced air removal Exposure Time: 4 minutes Exposure time can be extended to 18 minutes to comply with the recommendation from World Health Organization (WHO), Robert Koch Institute (RKI) etc. Stryker Trauma & Extremities medical devices are able to sustain such sterilization cycles. Temperature: 132 °C – 137 °C Drying Time: recommended: 30 minutes (minimum, in chamber) • Not for prion inactivation. Proceed according to local or national guidelines. • The integrity of the instruments is not influenced by sterilization temperatures lower than indicated above. It is the responsibility of the healthcare establishment to refer to the sterilizer manufacturer’s instructions for use for load configurations and sterilization accessories. Where appropriate the cleaned, disinfected, and checked medical devices should be assembled into the dedicated trays provided. Stryker Trauma & Extremities cases/trays should be double wrapped. It is the responsibility of the health care institution to make sure that appropriate cleaning, and sterilization methods are used where Stryker´s recommendations are not followed. 14 Notification • Please inform the manufacturer and the national authority, if a product related incident has occurred while using this device. • Australia: If you are noticing any incident that occurs in relation to the device report it directly to Stryker GmbH and to the Therapeutic Goods Administration (https://www.tga.gov.au/). 15 Transport and Storage Information The device is individually packed in protective packaging that is labelled according to its contents. Store and transport the device in the original protective packaging or the appropriately marked storage module/tray. Do not remove the device from the packaging until it is planned to be used or it is ready to be placed in the storage module/tray. Store the devices in standard hospital environmental conditions (cool and dry) unless specific requirements are defined and described on the product label.

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16 Special Training The healthcare professional must be licensed to perform surgery in the respective field of medicine and must be familiar with the principles of the surgical procedure. No mandatory training is required for the intended user group before using the VariAx Hand implants. 17 For Further Information Ensure that you are familiar with the intended purposes, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system. Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments. For your information, avail yourself of the training courses and publications offered (e.g. operative techniques). Important information for doctors and operating room (OR) staff: This package insert does not include all of the information necessary for selection and use of a device. Please see full labeling for complete information! • • • • • •

Instructions for use, operative techniques, “Instructions for Cleaning, Sterilization, Inspection and Maintenance” (OT-RG-1) and other associated labeling may be requested online at www.ifu.stryker.com. The use of the implants are described and/or illustrated in the operative technique of the product system. The applicable operative techniques for the VariAx Hand implants can be found on www.ifu.stryker.com. For a symbol explanation please refer to the glossary OT-IFU-210 on www.ifu.stryker.com. Please contact Stryker or your authorized representative if further information on this product is needed. If the product does not function satisfactorily, please contact your local Stryker representative or call Stryker Customer Service. The summary of safety and clinical performance is available in the European database on medical devices (Eudamed): https://ec.europa.eu/tools/eudamed.

18 Disposal The hospitals should follow the national regulations in force for medical waste disposal. Contaminated units should be decontaminated before they are discarded.

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Manufacturer:

Stryker GmbH

Content ID: VAX-IFU-30 Copyright © 2021 Stryker

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Bohnackerweg 1 2545 Selzach, Switzerland Phone: +41 (0) 32 641 66 66 Fax: +41 (0) 32 641 66 60 www.stryker.com