VariAx Instructions for Use

V15368 Rev AA, 02-2021

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 4 4 4 4 5

8 9 10 11 12 13 14

Magnetic Resonance Imaging (MRI) Information Informing the Patient Clinical Benefits Performance Characteristics Expected Lifetime Adverse Events and Adverse Effects Sterility, Cleaning and Sterilization

8 8 9 9 9 9 10

15 16 17 18 19

Notification Transport and Storage Information Special Training For Further Information Disposal

11 11 12 12 12

7.1 7.2 7.3

Pre-Operative Intra-Operative Post-Operative

6 6 7

14.1 Devices Delivered Sterile 14.2 Devices Delivered Unsterile or being Resterilized

2/13

10 10

V15368 Rev AA, 02-2021

VariAx® ALL OF THESE INSTRUCTIONS FOR USE MUST BE READ CAREFULLY PRIOR TO CLINICAL USE 1

Description and Material

The VariAx Screws include screws and washers. The screws and washers can be used with compatible plating systems, or as standalone implants. The VariAx Screws include Locking Screws, Locking Pegs, Bone Screws, Emergency Screws, and Washers. These implants are composed of the following materials: Component Locking Screws

Material Ti6Al4V ELI, anodization grade III

Locking Pegs

Ti6Al4V ELI, anodization grade III

Bone Screws

Ti6Al4V ELI, anodization grade III

Emergency Screws

Ti6Al4V ELI, anodization grade III

Washers

Ti6Al4V ELI or Titanium grade 4, anodization grade III

2

According to Standard ASTM F136 ISO 5832-3 AMS 2488D ASTM F136 ISO 5832-3 AMS 2488D ASTM F136 ISO 5832-3 AMS 2488D ASTM F136 ISO 5832-3 AMS 2488D ASTM F136 ISO 5832-3 AMS 2488D or ISO 5832-2 ASTM F67 AMS 2488D

Intended Purpose

The devices are non-active implants intended to provide temporary stabilization for bones or bone fragments.

3/13

V15368 Rev AA, 02-2021

3

Indications

The VariAx Screws are indicated for pediatric and skeletally mature patients, for internal fixation in the upper and lower extremities, clavicle and scapula in normal or osteopenic bone for the following conditions and procedures: • Fractures, including non-union • Arthrodesis • Osteotomy, including malunion • Reconstruction, including replantation 4

Contraindications

The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. 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. • Obesity (BMI ≥ 30)1, unless used with a compatible system that is indicated for obese patients. Obese patients can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself. • Patients having inadequate tissue coverage over the operative site. • Implant utilization that would interfere with anatomical structures or physiological performance. • 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 Screws 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 this system is adult and pediatric patients. 1

WHO (World Health Organization) generally considers a person with a BMI of 30 or more as obese (see https://www.who.int/topics/obesity/en/) 4/13

V15368 Rev AA, 02-2021

7

Warnings and Precautions • The licensed healthcare professional and operating room team must be thoroughly familiar with the operating technique, as well as the range of implants to be applied. Complete information and labeling on these subjects must be readily available at the workplace. • The implant is for single use only. • 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. • 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. • Always exercise care in selecting the proper type and size of implant. Improper selection, placement and fixation of the implant components may result in early implant failure. Implants can be available in different versions, varying for example in length, diameter, angle, right-hand and left-hand versions, material and number of drilled holes. The correct selection of the fracture fixation appliance is extremely important. Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure. Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone. The correct implant size for a given patient can be determined by evaluating the patient’s height, weight, functional demands and anatomy. Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation. • Fixation Screws: Stryker Osteosynthesis bone screws are not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. • Do not use components of Stryker product systems in conjunction with components from any other manufacturer’s system unless otherwise specified. • Always treat and use the instrument and implants carefully to avoid surface damage or alterations to the component geometry. • VariAx Screws are not designed to bridge bony gaps. Application of such may lead to premature implant failure. • Fracture treatment should be performed with a minimum of six cortices with non-locking 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. • Implants which consist of several components must only be used in the prescribed combination. • While rare, intra-operative fracture or breakage of instruments can occur. Instruments which have experienced excessive use or excessive force are susceptible to fracture. Instruments should be examined for wear or damage prior to surgery. • Locking screws and locking plates in conjunction with licensing agreement with Prof. D. Wolter, Hamburg, Germany. US Patent: 6,322,562. German Patent: DE 43 43 117. 5/13

V15368 Rev AA, 02-2021

7.1 Pre-Operative • Inspection is recommended prior to surgery to determine if implants have been damaged during storage. Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other. • Ensure that all components needed for the operation are available in the operation theatre. 7.2 Intra-Operative • Implants that came in contact with body fluids should never be reused. • Discard all damaged or mishandled implants. • During the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure. • Although all screws are selftapping, it is recommended to use a tap if excessive resistance is felt during insertion or if the bone is dense. • 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. When engaging a screwdriver blade within a screw head, the blade must be fully seated within the head of the screw. • Do not use locking screws in compression holes. • The Calcaneus Standard Plates (40-10112, 40-10114, 40-10116) are equipped with adaptation holes to facilitate plate placement onto bone. These holes are designed for use with 3.5 mm VariAx Non-Locking Screws. The adaptation holes will also accept VariAx 3.5 mm Locking Screws, but the locking strength may be reduced significantly in comparison to the circular holes. • 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 N°1059 (The ionising Radiation Regulations – Medical Exposure). • When engaging the screw, axial pressure of the screwdriver into the screw head must be adequately applied to ensure that the blade is fully inserted into the screw head. 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 lead to loss of friction fit performance. • In the distal region of the fibula, mono-cortical screw placement is recommended in order to avoid damage of the articular surface. • It is recommended to use a depth gauge before selecting the length of the screw. 6/13

V15368 Rev AA, 02-2021

• During drilling, tightening or extraction procedures through the plate metal debris can be generated. Debris removal is recommended. • Locking screws may not lock properly into the plate´s adaptation hole. Therefore we recommend using regular bone screws. • The angle of the inserted VariAx Locking Screw must not exceed 15°, except with the use of the VariAx Hand plates, in which case the angle of the inserted VariAx Locking Screw must not exceed 10°. • The lateral and dorsal medial VariAx Distal Radius plates (54-25400 to 54-25405) are not intended to be used to provide a rigid fixation for post operative early function. • The lateral and dorsal medial VariAx Distal Radius plates (54-25400 to 54-25405) should be used in combination with 2.3/2.7 mm locking or non locking screws. • For volar and dorsal VariAx Distal Radius plates 2.7 mm screws in the plate shaft shall be used. • Excessive tightening of the VariAx locking screw may lead to stripping of the locking threads. In the event that a locking screw thread strips out, a bone screw should be used. • 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. • Washers are specifically intended to provide additional surface area contact between the screw head and bone surface when used in combination with VariAx Non-Locking Screws for small bone reconstruction in the presence of a thin cortex. 7.3 Post-Operative • 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 implant is a short-term implant. 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 fracture or loosening of the implant or instability of the implant system. Regular post-operative examinations (e.g. X-ray checks) are advisable. • 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). • The patient should be closely monitored if a change at the fixation site has been detected. The licensed healthcare professional should evaluate the possibility of subsequent clinical failure, and discuss with the patient the need for any measures deemed necessary to aid healing. • Post-operative patient activity: These implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time. For this reason post-operative instructions and warnings to patients are extremely important. External immobilization (e.g. bracing or casting) may be employed until X-rays or other procedures confirm adequate bone consolidation. 7/13

V15368 Rev AA, 02-2021

• The risk of post-operative complication (e.g. failure of an implant) is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder. For this reason those patients must have additional post-operative follow-up. • 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. • For explantation, remain in the axis of the screw to avoid screw head failures. • Implant removal should be followed by adequate postoperative management to avoid fracture or refracture of the bone. 8

Magnetic Resonance Imaging (MRI) Information • Stryker VariAx Screws have not been evaluated for safety and compatibility in Magnetic Resonance (MR) environments and have not been tested for heating or migration in the MR environment, unless specified otherwise on the product labels and/or respective operative technique.

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. • Explain also the need to appear for the postoperative examinations (e.g. X-ray checks) and for the possible explantation of the implant. • The implantation affects the patient’s ability to carry loads and her/his mobility and general living circumstances. For this reason, each patient needs individual instructions on correct behavior after the implantation.

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 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. Explain also the need to appear for the postoperative examinations (e.g. X-ray checks) and for the possible explantation of the implant.

8/13

V15368 Rev AA, 02-2021

10 Clinical Benefits VariAx Screws are intended to provide temporary stabilization for osteosynthesis of bone and bone fragments using screws independently in a lag screw technique or in conjunction with a compatible Stryker plating system to support bone consolidation. 11 Performance Characteristics When used according to the manufacturer’s Instructions for Use and Labelling, VariAx Screws are intended to support bone consolidation by providing temporary stabilization of bones and bone fragments until bone consolidation has been achieved. 12 Expected Lifetime The lifetime for internal and external fixation devices is defined by their function in the human body. Internal or external fixation devices for osteosynthesis are intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved. But, it must be considered that these devices are developed based upon the available scientific knowledge at the time of design and manufacture. The current scientific literature on the time the fracture takes to heal, as related to the VariAx Screws or to the identified similar benchmark devices / state-of-the-art, is limited. However, the individual values reported on in seven separate data sources ranged from an average of 1 to 3 months for endpoints related to bone consolidation / healing. These devices are not intended to have a permanent function. It is known from the clinical literature that if bone consolidation is not achieved, these fracture fixation devices may break and will require removal. This, however, is dependent upon numerous individual factors, including but not limited to a patient’s pre-existing medical conditions, gender, age, body weight, bone quality, patient activity. 13 Adverse Events and Adverse Effects Complications which can occur as a consequence of osteosynthesis of bones and bone fragments using screws, may include the following clinical signs and symptoms: implant pain, discomfort, arthritis, numbness, postoperative wound infection, non-union of bone fracture, impaired healing, adhesion(s), loss of range of motion, foreign body reaction, hypersensitivity/ allergic reaction, nerve damage, malunion of bone, osteolysis, ossification, pain, fever, muscle/tendon damage, bone fracture. Device failure modes may include: implant loosening, implant breakage, implant migration, implant bending, malposition of device. In some cases, adverse effects associated with osteosynthesis may result in the need for additional or revision surgery.

9/13

V15368 Rev AA, 02-2021

14 Sterility, Cleaning and Sterilization 14.1

Devices Delivered Sterile

Products delivered sterile have been exposed to a minimum of 25 kGy of gamma radiation from a cobalt 60 source. • 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. Care must be taken to prevent contamination of the component. 14.2

Devices Delivered Unsterile or being Resterilized

• Products not labelled as sterile are 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. • Avoid drying of instruments after use for a more efficient cleaning process. Follow the instructions provided in the cleaning reprocessing and sterilization guide (OT-RG-1). • In case of blood or other fluids having dried on instrument module containers, lids, inlays or accessories, manual cleaning has to be performed before machine cleaning. • Exact compliance with the sterilizers manufacturers´ user instructions is required. • During sterilization direct contact between medical devices must be avoided. • All non-sterile products are sterilizable by steam sterilization (autoclaving). • 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. 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) 10/13

V15368 Rev AA, 02-2021

Alternative (e.g. UK, NL): Method: Moist heat sterilization according to EN ISO 17665 Cycle: Saturated steam with fractional forced air removal Exposure Time: 3 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: 134 °C – 138 °C Drying Time: recommended: 30 minutes (minimum, in chamber) • Not for prion inactivation. Proceed according to local or national guidelines. • Any cycle should be validated for different sterilization chambers, wrapping methods and/or various load configurations. To ensure access of the cleaning agent to all surfaces of instruments and accessories, a perforated stainless steel basket should be used. The washing machine cleaning process must permit the implants to remain still when they are cleaned. Washing machines should not be over-loaded. In accordance with the manufacturers´ instructions, add the necessary amount of washing and rinsing agent into the washing machine. 15 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/). 16 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.

11/13

V15368 Rev AA, 02-2021

17 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 VariAx Screws. 18 For Further Information Ensure that you are familiar with the intended purposes, indications/contraindications, compatibility and correct handling of the implant. 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. 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. 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.

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

12/13

V15368 Rev AA, 02-2021

Manufacturer:

Stryker GmbH

Content ID: VAX-IFU-19 Copyright © 2021 Stryker

13/13

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