Universal Neuro System Implants Instructions for Use

Table of Contents

1. Intended use / indications for use... 1

2. Contraindications... 2

3. Adverse Effects... 3

4. Self-Drilling Screws... 6

5. Emergency Self-Tapping Screws... 7

6. Material Information... 8

7. Cleaning... 9 7.1. Manual Pre-Cleaning Process (if applicable)... 9 7.2. Automated Cleaning Process... 9 7.3. Drying Process... 9 7.4. Sterilization... 10

8. Returns... 11

9. Warranty...12

1.

Intended use / indications for use

The Stryker Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non load bearing areas. All of these instructions for use must be read carefully prior to clinical use.

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2.

Contraindications

●● Non-reducible and unstable fractures. ●● Fractures of a severely atrophic bone. ●● Patients with active infections. ●● Patients with metal allergies and foreign body sensitivity. ●● Severely non-compliant patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions. ●● Patients with limited blood supply or insufficient quality or quantity of bone. ●● Patients with unstable physical and/or mental health conditions.

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3.

Adverse Effects

In many instances, adverse results may be clinically related rather than implant related. ●● Metal sensitivities or allergic reaction. ●● Severe bending and fracture of an implant. ●● Loosening of the implant as a result of insecure tightening. ●● Conditions attributable to non-union, bone necrosis, osteoporosis, bone reposition, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening; bending, cracking, fracture of the device or premature loss of fixation with the bone leading to non-union. ●● Improper alignment can cause a malunion and/or bending or fracture of the device. ●● Shortening of the affected bone/fracture site. ●● Dislocation of the device or migration into adjacent anatomical structures. ●● Early or late infection, both deep and/or superficial. ●● Subclinical nerve damage could possibly occur as a result of the surgical trauma. ●● Increased fibrous tissue response around the fracture site due to unstable comminuted fractures. ●● Delayed union, malunion or non-union of the fracture site resulting from improper alignment may lead to breakage of the implant. WARNINGS AND PRECAUTIONS General Information –– Single use devices cannot be reused, as they are not designed to perform as intended after the first usage. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications. Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization release. –– Use of Original Products: Universal Implants, instruments and accessories are produced and designed to be used together. The use of products from other manufacturers along with Stryker products can involve incalculable risks and/or contamination of the material and misalignments of implants and instruments, thereby endangering the patient, user or third parties. Only the products of one system should be used together. Pre-operative –– Only trained and experienced health care professionals should use this equipment. Before using any system component or any component compatible with this system, read and understand the instructions for use. Pay special attention to warning information, intended uses, indications/contraindications, compatibility and correct handling of the implant, instruments and accessories. Failure to comply may result in patient and/ or operating room staff injury as well as failure to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, or fracturing of the product and/ or bone. Before the operation ensure that all components needed for the operation are available and checked prior to use in the operation theatre. –– The correct selection and positioning of the device is extremely important. Success of the procedure requires the selection of the proper sizes, shapes and assembly of the fracture fixation appliances. –– All materials from products which are not specified as implants must not be implanted and have to be removed from the patient.

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–– The safety and effectiveness of the implant is not known when used in patients who have undergone or who are to undergo radiation therapy at or near the implant site. –– The effect of the device on patients with the following is not known: –– Pregnancy/Nursing –– Defects due to disease or congenital malformation –– Infection during the last three months and/or a history of chronic infection –– Contamination by non-conventional transmissible agents, e.g. vCJD, in accordance with the system indications for use, particularly through contact with lymphatic tissue, is possible. Stryker recommends incinerating any product that is suspected to have been contaminated by non-conventional transmissible agents. –– Patient Information: The surgeon should discuss the expectations of the surgery inherent with the use of the product with the patient. Particular attention should be given to a discussion postoperatively and the necessity for periodic medical follow-ups. –– The device should be implanted only in a sterile field. –– Responsibility for proper selection of the patient, adequate training, experience in the choice and placement of implants and the decision to leave or remove implants postoperatively, rest with the surgeon. Post-operative –– Regular post-operative examinations (e.g. X-ray checks) are advisable. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture of the bone. –– Stryker implants are not compatible with magnetic resonance imaging (MRI) techniques, unless specified otherwise in the product labeling or respective product technical guides. –– The bone plates are designed to function only until bony healing (usually 6-10 weeks). –– The patient should be advised to report any unusual changes of the operated site to his surgeon and should be closely monitored if a change at the fixation site has been detected. The surgeon should evaluate the possibility of subsequent clinical failure, and discuss with the patient the need for any measures deemed necessary to aid healing. –– Fracture fixation: a minimum of 2 screws should be rigidly fixated within the plate on each side of the fracture if possible. Postoperative care must be followed. Additional fixation may also be necessary as deemed appropriate by the surgeon. Plate Warnings and Precautions –– Avoid surface damage of implants and discard all damaged or mishandled implants. –– Excessive bending can cause recognizable macroscopic damage to the implant (indentations, elongated screw holes, etc.) and lead to postoperative plate fracture. If contouring is necessary, sharp bends, reverse bends or bending the device over screw holes should be avoided. The desired shape has to be reached in a few bends as possible. Plates that have been severely bent and re-bent should be discarded. –– Deformed plate holes signify not only an increased risk of breakage in these areas but also impair the accurate fit of the screw head to the plate. Plates should be bent with care. –– Excessive tightening can lead to titanium particles, which have to be removed. –– A cut bone plate segment to be implanted may require deburring to prevent soft tissue injuries or irritations. –– Plates should be contoured anatomically to the bone as closely as possible. Gaps between the plate and the bone should be avoided. –– Low Profile Neuro plates (color coded teal) and Standard Neuro plate (color coded gold) should only be used with the 1.5 mm self-tapping or self-drilling screws from their respective module. –– When using self-drilling screws, the tip of the screw should be placed in the center of the screw hole. When using self-tapping screws, ensure that the predrilled hole is in the center of the new screw hole. –– Neuro implants are not designed to bridge bony gaps in cases of un-reducible, unstable comminution or reconstruction. Application of such may lead to premature implant failure. Screw Warnings and Precautions General information/bone screws –– 1.5 mm self-tapping and self-drilling screws utilize the same screwdriver blade. This blade is marked with teal bands around the blade.

Adverse Effects | 4/12

–– It is recommended to use a Universal Neuro Screwdriver handle. –– Placement of self-tapping screws requires the use of a predrilled hole. A drill bit with different couplings adapted to the longest screw in the set is available and color coded with a teal band. –– Regardless of the geometry of the screwdriver recess in the head of the bone screw it is essential to ensure that the screwdriver/ screw head connection is exactly aligned in the vertical direction; otherwise there will be an increased risk of mechanical damage to the implant or the screwdriver blade. –– The diameter and the length of the screw can be compared via the screw scale on the screw disc or module inlay. This scale is adapted specifically to the Low Profile Neuro Screws. –– The screw must be fully inserted into the screw head recess of the plate to provide the maximum functionality. –– In the final phase of screw insertion, the underside of the screw head contacts the screw head recess of the bone plate and a steep rise in resistance is clearly perceptible. Sensitive tightening of the screw must be exercised to reduce the risk of mechanical damage to the screw, screwdriver, or bony hole. –– Excessive screw tightening may lead to stripping of the threads. In the event that a screw thread strips out, an emergency screw should be used. –– 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 the blade and the screw. –– 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 round-out. Otherwise, there will be an increased risk of mechanical damage to the implant or the screwdriver blade.

Adverse Effects | 5/12

4.

Self-Drilling Screws

It is recommended that shorter screws (shorter than or equal 4 mm) be used in bone that is known to be dense in order to avoid excessive axial forces and torque. Should the screws be difficult to start or insert in bone, a pilot hole should be drilled to facilitate insertion, especially for use of screws with a length of more than 4 mm. Application of a constant downward/axial force on the screwdriver handle and exact screwdriver/screw alignment are recommended during screw insertion to ensure that the blade-to-screw head interface is maintained. This increase in resistance might not be clearly perceived during final tightening. Extra care should be applied in tightening the screw to reduce the risk of mechanical damage to the screw, screwdriver or placement site.

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5.

Emergency Self-Tapping Screws

Emergency screws are recommended to be used when a self-drilling or self-tapping screw strips the bone. Emergency screws are selftapping screws. If a self-tapping screw strips the bone, an emergency screw can be used directly. After stripping by a self-drilling screw, a pilot hole needs to be drilled in order to fixate the emergency screw properly and to avoid further screw stripping.

Emergency Self-Tapping Screws | 7/12

6.

Material Information

Stryker bone plates and bone screws may be made of commercially pure titanium or Ti6AI4V alloy (acc. to ASTM F67, ASTM F136/ ISO 5832-3). Both materials are biocompatible, corrosion-resistant and non-toxic in the biological environment, and produce negligible artifacts by X-ray and CT.

Material Information | 8/12

7.

Cleaning

●● It is the responsibility of the user facility to make sure that appropriate and validated cleaning methods are used where Stryker recommendations are not followed. Exact compliance with the equipment manufacturer’s user instructions and recommendations for chemical detergents is required ●● Contaminated implants have to be disposed of properly. ●● New products must be carefully cleaned before initial sterilization. Trained personnel must perform cleaning along with maintenance and mechanical inspection prior to initial sterilization. Both manual and machine cleaning methods can be used. Whenever possible, the washing machine should be used to avoid prolonged contact with contaminated devices and the cleaning agents. ●● If implants become contaminated in the module, they must be carefully cleaned manually before it is cleaned in a washer. ●● Implants should be cleaned in accordance with the following decontamination and cleaning specifications: Preparation of Washing and Rinsing Agents –– Avoid contact between devices (movement during washing could cause damage and washing action could be obstructed). It is recommended that all implants be cleaned within the supplied implant modules. Washing machines should not be overloaded. –– In accordance with the manufacturer´s instructions, add the necessary amount of washing and rinsing agent into the washing machine. Stryker recommends only the use of neutral pH cleaning and disinfecting agents.

7.1. Manual Pre-Cleaning Process (if applicable) For pre-cleaning use suitable cleaning agents, brushes or cleaning wires. Clean the medical device thoroughly, paying particular attention to rough surfaces and features where soil may be shielded from the brushing. Manual pre-cleaning temperature should not exceed 122 °F (50 °C).

7.2. Automated Cleaning Process In accordance with EN ISO 15883, the following phases should be adhered to: ●● Washer disinfector with fundamentally approved efficiency, properly installed, qualified and regularly maintenanced and tested. ●● Approved thermal disinfection program (A0 value > 3000 or – in case of older devices – application of at least 5 min at 194 °F (90 °C); chemical disinfection program not recommended (danger of remnants of the disinfectant on the implants)) with sufficient rinsing steps and filtered air for an active drying program (application of rinsing aids not recommended, danger of remnants). ●● Final rinsing / disinfection only with freshly prepared Purified Water/Highly Purified Water.

7.3. Drying Process ●● Remove the implant module(s) upon completion of the cleaning process. ●● If the decontamination-cleaning process does not include a drying cycle, thoroughly dry the implants in an oven at a temperature below 230 °F (110 °C).

Cleaning | 9/12

7.4. Sterilization If not expressly specified as sterile, the product is supplied non-sterile. ● Caution: Sterile products are sterile only if the package is not damaged or opened! ● Exact compliance is required with the manufacturers´ user instructions for sterilizers. ● It is the responsibility of the user facility to make sure that appropriate sterilization methods are used where Stryker recommendations are not followed to account for potential differences in sterilization chambers, wrapping methods and load configurations. ● All non-sterile products are sterilizable by steam sterilization (autoclaving). For initial sterilization and resterilization, the following parameters can be used: Gravity Sterilization

Immediate Use (Flash Gravity) Sterilization (see “caution2”)

Sterilizer Type Vacuum assisted Vacuum assisted Gravity dissterilizer sterilizer placement sterilizer Wrapping Double wrapped in the Universal Sterilization Container

Cycle Type

SterilizationTemperature Minimum Exposure Time for Sterilization Minimum Drying Time

Prevacuum (3-times prevac)

Prevacuum (3-times prevac) (see “caution1”)

270 °F (132°C)

274 °F (134°C)

270 °F (132°C)

Gravity displacement sterilizer Unwrapped in the Universal Sterilization Container 270 °F (132°C)

4 min.

3 min.

34 min.

10 min.

45 min.

45 min.

45 min.

Immediate use (see “caution2”)

Container is wrapped using the AAMI (Association for the Advancement of Medical Instrumentation) CSR double wrapping technique. This cycle was validated with only one system in the chamber and using the middle shelf. CAUTION1 The Prevacuum Cycle (274 °F @ 3 min) shall not be used within the USA and markets requiring FDA submission approval. Caution2 The “Immediate Use (Flash) Sterilization process” is only allowed for use in the USA. Immediate Use Sterilization should not be used on implants, except in a documented emergency situation when no other option isavailable. According to the CDC, a few adverse events including an increased risk of infection have beenassociated with Immediate Use Sterilization1. The processed items must be transferred immediately, usingaseptic technique. Reduction of bioburden and removal of gross soil are essential steps in preparing an itemfor sterilization by any method. After sterilization, allow the product to cool to room temperature prior to use.(1 CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008).

Cleaning | 10/12

8.

Returns

Return the unit to your local Stryker distribution center. All returns require a returned material authorization (RMA) number, which can be obtained through a sales representative. Open products cannot be returned for credit.

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9.

Warranty

Suitability for use of the medical device for any surgical procedure shall be determined by the health care provider. Stryker shall not be liable for incidental or consequential damages of any kind. Federal law in the USA restricts this device to sale by or on the order of a physician. See product label for information regarding the specific product referenced in this package insert.

Warranty | 12/12

Manufactured and distributed by: Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg (Germany) t: +49 761 4512 0 Distributed in the USA by: Stryker Craniomaxillofacial Kalamazoo, MI 49002 (USA) t: +1 800 962 6558 f: +1 822 648 7114

Stryker Corporation or its divisions or other affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, Universal Neuro. All other trademarks are trademarks of their respective owners or holders. Copyright © 2016 Stryker

0197

2015-07-09

90-01948 | 6 | EN

www.stryker.com