PATHFINDER NXT MINIMALLY INVASIVE PEDICLE Instructions for Use

(English) IMPORTANT INFORMATION FOR PATHFINDER NXT™ MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Before using a product placed on the market by Zimmer Biomet, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available productspecific information (e.g., product literature, written surgical technique) which can be obtained by using the Zimmer Biomet contact information included with this package insert. Zimmer Biomet is not liable for complications arising from the use of the device outside of its indicated uses, surgical technique or judgment, product selection, and similar matters outside the control of Zimmer Biomet. Compatibility between all Zimmer Biomet Spine product lines, including acquisitions of pre-existing product lines, has not been established. Only authorized combinations of products should be used. Only use as indicated in the Instructions for Use (Package Insert) and/or the Surgical Technique. DESCRIPTION The Zimmer Biomet Spine PathFinder NXT™ system consists of polyaxial cannulated screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine. A range of spinal rod lengths included with PathFinder NXT allows the surgeon to place polyaxial pedicle screws through an open or mini-open procedure. The PathFinder NXT System is designed to aid in the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with autograft or allograft. These implants are intended to be removed after the development of a solid fusion mass. Refer to the PathFinder NXT Minimally Invasive Pedicle Screw System Indications for Use for complete information on the PathFinder NXT System. The PathFinder NXT System only allows the placement of 5.5 mm titanium rods. Refer to the PathFinder NXT Surgical Technique Manual for instructions on implantation. INDICATIONS PathFinder NXT System – mini-open posterior approach When intended for pedicle screw fixation from T1 – S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion. As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established. 1

CONTRAINDICATIONS 1. Disease conditions which have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices. 2. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. 3. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other posterior spinal instrumentation system. 4. Any entity or condition that totally precludes the possibility of fusion, i.e. cancer, kidney dialysis or osteopenia, is a relative contraindication. Other relative contraindications include obesity, pregnancy, certain degenerative disease, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant. See also the WARNINGS, PRECAUTIONS and ADVERSE EFFECTS sections of this insert. MATERIALS Components of the PathFinder NXT System are offered in titanium alloy Ti 6Al-4V ELI (ASTM F-136) and unalloyed Titanium (ASTM F67). Stainless steel and titanium components should not be used in the same construct. INSPECTION All implants and instruments should be thoroughly inspected for damage or wear prior to use. If damage or wear is noted that may compromise the proper function of the implant, instrument or instrument cases, do not use and contact customer service or your Zimmer Biomet Spine representative for a replacement. STERILIZATION HANDLING The PathFinder NXT implants and instrumentation are supplied non-sterile. Implants are intended for single use only and should never be reused. While the implant may appear undamaged, imperfections may exist which would reduce its service life. Non-sterile products must be sterilized before use. PathFinder NXT implants should never be re-sterilized after contact with body tissues or fluids. Universal precautions for handling contaminated/biohazard material should be observed. Decontamination of all reusable instruments and trays is required prior to returning to Zimmer Biomet Spine. STORAGE AND HANDLING Implants and Instruments in their original packaging should be stored in a dry environment, away from aggressive or oily chemicals. Re-usable instruments should be cleaned and sterilized after each use and stored in a dry environment in the appropriate cases/trays in the configuration specified by Zimmer Biomet Spine. 2

Single-use implants should be stored in a dry environment in the appropriate cases/trays, as provided by Zimmer Biomet Spine. Implants and instruments should not be stored next to aggressive chemicals. CLEANING AND DECONTAMINATION STEPS FOR NON-STERILE INSTRUMENTS Non-sterile instruments of the PathFinder NXT System are delivered clean but NOT STERILE and must be thoroughly cleaned and sterilized before use. It is the responsibility of the healthcare institution to clean the instruments prior to use, according to the following validated methods. Remove all packaging materials prior to sterilization. Expose all threaded components. Exposing threads allows access for cleaning, lubricating and sterilization and releases any trapped fluids. Use a guide wire to push any debris out of any inner lumens. Clean all instruments prior to use, and as soon as possible after use. Do not allow blood and debris to dry on the instruments. If cleaning must be delayed, place instruments in a covered container with appropriate detergent or enzymatic solution to delay drying. Instrument Disassembly/Assembly Instructions • Disconnect modular handles from all instruments prior to cleaning and sterilization (Screwdrivers, Taps, Closure Top Drivers, In-line Rasp). • Remove Locking Pins from Extender Sleeves prior to cleaning and sterilization. • Disassemble Rod Calipers prior to cleaning and sterilization. • Remove all disposable instrument components (K-wires, Pedicle Access Tool Trocar, Pedicle Access Tool Aspiration Adaptor, Pedicle Access Tool Sheath, Tissue Dilator C) prior to cleaning and sterilization. The following cleaning instructions are consistent with processional recommendations and with United States Occupational Safety and Health Administration regulations for minimizing occupational exposure to blood-borne pathogens and toxic chemicals. For optimal results, instruments should be cleaned within 30 minutes of use or after removal from solution to minimize the potential for drying prior to cleaning. CLEANING INSTRUCTIONS 1. Wear Personal Protective Equipment (PPE) when handling or working with contaminated or potentially contaminated materials, devices, and equipment. PPE includes gown, mask, goggles or face shield, gloves, and shoe covers. 2. Remove excess body fluids and tissue from instruments with a disposable, non-shedding wipe. Place instruments in a basin of distilled water or in a tray covered with damp towels. DO NOT allow saline, blood, body fluids, tissue, bone fragments, or other organic debris to dry on instruments prior to cleaning. 3. Prepare a neutral enzyme cleaning solution at the use-dilution and temperature recommended by the product manufacturer. Tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents. 3

4. Completely submerge instrument(s) in the neutral enzyme solution and allow soaking for 20 minutes. Scrub using a soft-bristled, nylon brush until all visible soil has been removed. 5. Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of the devices. 6. Remove the device from the enzyme solution and rinse in warm tap water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult to reach areas. 7. Place prepared neutral cleaning agents in a sonication unit. Completely submerge device in cleaning solution and sonicate for 10 minutes at 45–50 kHz. 8. Rinse instrument in reverse-osmosis (RO)/deionized (DI) water for at least 3 minutes or until there is no sign of blood or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, holes and other difficult to reach areas. 9. Repeat the sonication and rinse steps above. 10. Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe. WARNING: Usage of automated cleaning processes without supplemental manual cleaning may not result in adequate cleaning of instruments. CLEANING INSPECTION 1. Carefully inspect each instrument to ensure that it is visually clean and all visible contamination has been removed. This is the endpoint of the cleaning process, and only at this point may the instrument be sterilized. If contamination is noted, repeat the disinfection process. If after multiple cleaning processes the instrument cannot be made visibly clean, do not use and contact customer service or your Zimmer Biomet Spine representative for a replacement. 2. Inspect instruments and instrument cases for damage/wear prior to use. 3. Check action of moving parts (e.g. hinges, box-locks, connectors, sliding parts, etc.) to ensure smooth operation through the intended range of motion. 4. Check instruments with long slender features (particularly rotating instruments) for distortion. 5. Where instruments form part of a larger assembly, check that devicesassemble readily with mating components. 6. If damage or wear is noted that may compromise the proper function of the instrument or instrument case, do not use and contact customer service or your Zimmer Biomet Spine representative for a replacement. 7. If corrosion is noted, do not use and contact customer service or your Zimmer Biomet Spine representative for a replacement. STERILIZATION OF NON-STERILE IMPLANTS AND INSTRUMENTS All implants and instruments are supplied visually clean and non-sterile. They must be sterilized prior to use in their specific case, tray and lid. It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators and sterilization cassettes) that have been cleared by the US Food and Drug Administration for the selected sterilization cycle specifications (time and temperature). 4

Disinfection is only acceptable as a precursor to full sterilization for reusable surgical instruments and single-use implants. The end user is responsible for in-house procedure for the inspection and packaging of the instruments, after they are thoroughly cleaned in a manner that will ensure steam sterility penetration and adequate drying. Provisions for protection against any sharp or potentially dangerous areas of the instruments should also be recommended by the end user. Sterilizer manufacturer recommendations should always be followed. When sterilizing multiple instruments sets, during one sterilization cycle, do not stack trays and ensure that the manufacturer’s maximum load is not exceeded. Steam (moist heat) is the recommended sterilization method for Zimmer Biomet implants and instruments. Ethylene oxide (EO), gas plasma and dry heat sterilization methods are not recommended for sterilization of Zimmer Biomet reusable instruments and single-use implants. Routine monitoring per AORN recommended practices for in-hospital sterilization should be followed. Instruments should be positioned to allow the sterilant to come into contact with all surfaces. All jointed instruments should be in the open or unlocked position with ratchets not engaged. Instruments composed of more than one part or with sliding pieces or removable parts should be disassembled. Remove all packaging material prior to sterilization. Only sterile implant and instruments should be used in surgery. ALWAYS immediately re-sterilize all implant and instrument kits used in surgery as well as any unused implant kits that were in the surgical suite. All instruments and implants must be loaded in the trays provided in the designated locations as indicated by the tray markings prior to sterilization. All implant caddies and implants must be placed in the tray prior to sterilization. The following sterilization cycles have been laboratory validated by Zimmer Biomet Spine to provide a 10-6 sterility assurance level (SAL): Method: Cycle: Temperature: Exposure Time: Wrapping: Wrap Type: Drying Time:

Steam Pre-Vacuum 270°F (132°C) 4 minutes 2 layers One Ply Polypropylene Wrap KC600 45 minutes

Routine monitoring per AORN recommended practices for in-hospital sterilization should be followed. Instruments should be positioned to allow the sterilant to come into contact with all surfaces. All jointed instruments should be in the open or unlocked position with ratchets not engaged. Instruments composed of more than one part or with sliding pieces or removable parts should be disassembled. Remove all packaging material prior to sterilization. Only sterile implants and instruments should be used in surgery. Always immediately re-sterilize all implant and instrument kits used in surgery as well as any unused implant kits that were in the surgical suite. 5

FDA cleared wraps are recommended for use with your sterilization tray. Although Zimmer Biomet Spine provides these sterilization instructions to you for your use, following these sterilization instructions is ultimately the responsibility of the healthcare facility and in no event will Zimmer Biomet Spine be held liable for the sterility of devices where these sterilization instructions are not followed by the healthcare institution. GENERAL RE-PROCESSING Zimmer Biomet Spine recommends users to document the completion of critical reprocessing steps and inspections to help the manufacturer understand the causes of device failures attributed to misuse or improper reprocessing. The user/processor should comply with local laws and ordinances in countries where reprocessing requirements are more stringent than those detailed in this manual. INSTRUMENT CARE-SPECIAL PRECAUTIONS Proper handling, decontamination (including pre-rinsing, washing, rinsing and sterilization), storage and utilization are important for the long and useful life of all surgical instruments. Even with correct use, care and maintenance, they should not be expected to last indefinitely. This is especially true for cutting instruments and implant insertion instruments. These items are often subjected to high loads and/or impact forces. Under such conditions, breakage can occur, particularly when the item is corroded, damaged, nicked or scratched. Universal precautions should be observed by all end users that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges to prevent injuries during and after surgical procedures and reprocessing. POSTOPERATIVE MOBILIZATION Careful patient handling for two to four months post-operatively is very important while the fusion mass matures and becomes able to share load with the implant. Until X-rays confirm maturation of the fusion mass, external mobilization (such as bracing or casting) is recommended. Instructions to the patient to reduce stress on the implant are an equally important part of the attempt to avoid the occurrence of clinical problems that may accompany fixation failure. In younger patients, once the fusion mass has healed, the implants may be removed to allow the fused bone to return to a better state of load transfer. This is, as with all patient care, left to the discretion of the operating surgeon. WARNINGS Following are specific warnings, precautions, and adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery. 1. IN THE U.S.A., THIS PRODUCT HAS LABELING LIMITATIONS. 6

2. THE SAFETY AND EFFECTIVENESS OF PEDICLE SCREW SPINAL SYSTEMS HAVE BEEN ESTABLISHED ONLY FOR SPINAL CONDITIONS WITH SIGNIFICANT MECHANICAL INSTABILITY OR DEFORMITY REQUIRING FUSION WITH INSTRUMENTATION. These conditions are significant mechanical instability secondary to degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions is unknown. 3. BENEFIT OF SPINAL FUSIONS UTILIZING ANY PEDICLE SCREW FIXATION SYSTEM HAS NOT BEEN ADEQUATELY ESTABLISHED IN PATIENTS WITH STABLE SPINES. Potential risks identified with the use of this device system, which may require additional surgery, include: a) Device component fracture. b) Loss of fixation. c) Non-union. d) Fracture of the vertebra. e) Neurological injury. f) Vascular or visceral injury. 4. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape, and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. 5. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NON-UNION. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed or does not occur, the implant may eventually break due to metal fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. 6. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion 6. damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, wires, etc. which come into contact with other metal objects, must be made from like or compatible metals. 7. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure: 7

a) The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation. b) The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes substantial walking, running, lifting or muscle strain, the resultant forces can cause failure of the device. c) A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications. d) Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary relief. e) Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. f) Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where autograft or allograft is used. PRECAUTIONS 1. THE IMPLANTATION OF PEDICLE SCREW SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS PEDICLE SCREW SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. 2. SURGEONS SHOULD HAVE KNOWLEDGE OF HOW TO TARGET PEDICLE SCREWS USING FLUOROSCOPY AND K-WIRE WHEN UTILIZING A MINIOPEN OR PERCUTANEOUS SURGICAL TECHNIQUE. 3. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be re-implanted. Even though the device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage. 4. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of the metal implants should only be performed with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease fatigue life and may cause failure. 5. REMOVAL OF THE IMPLANT AFTER HEALING. Metallic implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after healing, particularly in young, active patients. The surgeon should carefully weigh the risk versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risk involved with a second surgery. 8

6. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in bending or fracture. The patient should understand that a metallic implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation. 7. All implants and some instruments are intended for single-use only; refer to the product label to determine if the instrument is single use only. Single use devices should not be re-used. Possible risks associated with re-use of single-use devices include: • Mechanical malfunction • Transmission of infectious agents MAGNETIC RESONANCE IMAGING (MRI) SAFETY AND COMPATIBILITY INFORMATION The Pathfinder NXT System has not been evaluated for safety and compatibility in the MR (Magnetic Resonance) environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Pathfinder NXT System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. In the event of exposure to foreseeable environmental conditions such as magnetic fields the user and/or patient should be informed of the following: PRECAUTIONS • This device has not been evaluated for safety and compatibility in the MR environment. • This device has not been tested for heating or migration in the MR environment. • There is a potential for heating and migration in the MR environment. • There is the potential for metal implants to create MR imaging artifacts in the vicinity of the implant. POSSIBLE ADVERSE EFFECTS Complications and adverse reactions have been reported with the use of similar spinal instrumentation systems. These adverse effects, including the possibility of death, should be discussed with the patient prior to surgery. • Non-union, delayed union. • Bending or fracture of implant. Fraying, kinking, loosening, bending or breaking of any or all of the cable implant components. • Loosening of the implant. • Metal sensitivity, or allergic reaction to a foreign body. • Infection. • Decrease in bone density due to stress shielding. 9

• • • • • • • • •

Pain, discomfort, or abnormal sensations due to the presence of the device Loss of proper spinal curvature, correction height and/or reduction. Cable cutting through soft osteoporotic, osteogenic or cancellous bone. Vascular and/or nerve damage due to surgical trauma or presence of the device. Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia. Bursitis. Dural leak. Paralysis. Death. Erosion of blood vessels due to the proximity of the device, leading to hemorrhage and/or death.

PATIENT COUNSELING INFORMATION Complications and/or failure of spinal implants are more likely to occur in patients with unrealistic functional expectations, heavy patients, smokers, physically active patients, and/or patients who fail to comply with postoperative treatment requirements. There is a risk that the implant may fracture or loosen from any variety of causes including, in the case of a fusion device, from failure to obtain fusion. Spinal implants are not as strong, reliable, or durable as natural, healthy tissues/bones, therefore such devices may require removal or revision. The patient must be counseled on all postoperative restrictions, particularly those related to occupational and recreational activities (e.g., sports) and the possibility that the implant or its components may be temporary, fail, or require revision. The CE mark is valid only if it is also printed on the product label. ADDITIONAL TRANSLATIONS • • • • • • • • • • • •

Nitinol Only Tap Lock Unlock Forward Reverse Sleeve Line Initial Position Screw Line This Side Short Long Extender Sleeve Power Rod Reducer 10

To obtain a copy of the surgical technique or request additional information, contact your local sales representative or call U.S. Customer Service at +1 800.447.3625. CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. The CE mark is valid only if it is also printed on the product label. WARRANTY Refer to the Zimmer Biomet Spine Price List/Catalog for further information about warranties and limitations of liability.

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Commonly Used Symbols for Medical Devices Note: Refer to the individual package label and the back cover of this leaflet for symbols applicable to the product. <Manufacturer> <Date of Manufacture> <Use by Date> <Do Not Re-use> <Do Not Re-sterilize> <Do Not Use If Package Is Damaged> <Diameter> <Caution, Consult Accompanying Documents> <Non-sterile> <Sterilized Using Ethylene Oxide> <Sterilized Using Irradiation>

QTY

<Quantity in Package> <Batch Code> <Catalogue Number> <Authorized Representative in the European Community>

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<Federal (USA) law restricts this device to sale by or on the order of a physician> <Consult Instructions for Use>

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Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster, CO 80021 USA +1 800.447.3625 zimmerbiomet.com

07.01526.001 Rev. E 2017-03 (07.00230.101)

Zimmer GmbH Sulzerallee 8 CH-8404 Winterthur Switzerland +41 058.854.80.00 Country of Origin: U.S.A. Printed in U.S.A. ©2017 Zimmer Biomet Spine, Inc.

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