Vitality Spinal Fixation System Instruction Manual

CONTRAINDICATIONS The Vitality System is not designed or sold for any use except as indicated. DO NOT USE THE VITALITY SYSTEM IMPLANTS IN THE PRESENCE OF ANY CONTRAINDICATION. • Insufficient bone quantity, severe osteoporosis, or other condition that might compromise rigid fixation of the device. • A history of infection, active systemic infection or infection localized to the site of the proposed implantation. • Suspected or documented metal allergy or intolerance. • A disorder affecting the normal process of bone remodelling, including but not limited to severe osteoporosis involving the spine, excessive bone reabsorption, osteopenia, a primary or metastatic tumor involving the spine, or certain metabolic disorders of osteogenesis. • Iliac screws and offset connectors should not be used in cases of tumor or trauma of the sacrum, when additional screw fixation in S1 is not possible. • Other relative contraindications include obesity, pregnancy, certain degenerative diseases, 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. WARNINGS AND PRECAUTIONS Following are specific warnings, precautions, and adverse effects associated with use of the Vitality System that should be understood by the surgeon and explained to the patients. General surgical risk should be explained to the patients prior to surgery. • Implantation of the Vitality System should be performed only by experienced spinal surgeons. • All implants are intended for 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 • Metal sensitivity has been reported following exposure to orthopedic implants. The most common metallic sensitivities (nickel, cobalt, and chromium) are present in medical grade stainless steel and cobalt-chrome alloys. • 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. • Warning: 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 or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5‑S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. • Warning: The safety and effectiveness of this device has not been established for use as part of a growing rod construct. The device is only intended to be used when definitive fusion is being performed at all instrumented levels.

• Additional Warnings for Pediatric Patients: The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw malpositioning and neurological or vascular injury. Patients who are not skeletally mature undergoing spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine. • Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal 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. • Additional Precautions for Pediatric Patients: The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system in pediatric patients. The selection of the proper size, shape and design of the implant for each patient is crucial to the safe use of this device in pediatric patients. Additional preoperative, intraoperative, warnings and precautions:

and

postoperative

PREOPERATIVE • Usage of automated cleaning processes without supplemental manual cleaning may not result in adequate cleaning of instruments. • 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 (e.g., bone awls/drills) and driving instruments (e.g., drivers). 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. • Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct; otherwise, galvanic corrosion may occur. • Zimmer Biomet does not specify the maximum number of times a re-usable instrument may be re-used. The useful life of these instruments is highly dependent on a number of factors including the frequency and manner in which they are used and the handling they experience in between uses. Inspection and, where appropriate, functional testing prior to using, is the best way to determine whether or not an individual device should be used. INTRAOPERATIVE • If contouring of the implant is necessary for optimal fit, the contouring should be gradual and avoid any notching or scratching of the implant surface. Do not repeatedly or excessively bend the implant. Do not reverse bend the rods.

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• Pedicle bone integrity should be verified. • Care should be taken during pedicle preparation to avoid penetrating too deep. • Care should be taken during bone preparation to avoid damage to the pedicle and to the surgical instruments.

• Erosion of blood vessels due to the proximity of the device, leading to hemorrhage and/or death • Additional surgery may be required to correct any of these potential adverse effects • Additional Potential Adverse Effects for Pediatric Patients:

• Care should be taken to minimize soft tissue damage during surgery.

1. Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)

• Care should be taken to avoid removing excess material from the lamina.

2. Pedicle screw malpositioning, with or without neurological or vascular injury

• Care should be taken to avoid cross-threading screws and closure tops.

3. Proximal or distal junctional kyphosis

• If any implant or instrument comes in contact with a nonsterile surface it should not be used. POSTOPERATIVE • 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 fracture. The patient should understand that an 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. • The Vitality System is a temporary internal fixation device. Internal fixation devices are designed to stabilize the operative site during the normal healing process. After healing occurs, these devices serve no functional purpose and should be removed. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. 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 implant components. • Loosening of or migration of the implant • Metal sensitivity or allergic reaction to a foreign body • Infection • Decrease in bone density due to stress shielding • Pain, discomfort, or abnormal sensations due to the presence of the device • Loss of the natural curvature of the spine • Modification of the spinal geometric corrections of the vertebral and/or intervertebral height and/or of the reduction in spinal deformities • 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

4. Pancreatitis Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients, and pediatric patients may be at increased risk for device-related injury because of their smaller stature. MATERIALS Implants: The Vitality System implants are fabricated from medical grade titanium alloy per ASTM F136 and medical grade cobalt chromium alloy per ASTM F1537. Instruments: The Vitality System instrumentation is generally made from stainless steel, aluminum, titanium, and polymeric materials. CLEANING Implants Implants should not be cleaned. Implants are provided clean and NOT STERILE. The implants must be sterilized before use. If an implant is soiled and/or contaminated, it should be discarded according to standard biohazard disposal procedures. All implants must be inspected prior to use for damage or wear. If damage or wear is noted, do not use and contact customer service or your Zimmer Biomet Spine representative for a replacement. Instruments The Vitality System instruments are reusable. It is the responsibility of the healthcare institution to clean the instruments prior to use, according to the following validated methods. The following cleaning instructions are consistent with professional recommendations and with United States Occupational Safety and Health Administration regulations for minimizing occupational exposure to blood-borne pathogens and toxic chemicals. Instrument Disassembly/Assembly Instructions 1. Disconnect modular handles from all instruments prior to cleaning. 2. Disassemble the Tower Rod Reducer and Multi-Piece Screw Driver instruments before cleaning. Reassemble the Tower Rod Reducer and Multi-Piece Screw Driver after cleaning and prior to sterilization. 3. Separate Screw Drivers and Screw Driver Sleeves before cleaning. 4. Expose all threaded components. Exposing threads allows access for cleaning, lubricating and releases any trapped fluids. Use a guide wire to push any debris out of any inner lumens. Note: The Multi-Piece Screw Driver is an optional instrument not available in all kit configurations. 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. 07.02199.001-en REV 05 2019-11

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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.

5. Where instruments form part of a larger assembly, check that devices assemble readily with mating components.

3. Prepare a neutral enzyme cleaning solution at the usedilution and temperature recommended by the product manufacturer. Softened tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents.

7. If corrosion is noted, do not use and contact customer service or your Zimmer Biomet Spine representative for a replacement.

4. Completely submerge instrument(s) in neutral enzyme solution and allow soaking for 20 minutes. Thoroughly clean by scrubbing 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. Note: Ensure the Tower Reducer’s handle is completely flushed near the button and underneath the handle by the shaft. 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 purified 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. Refer to the Vitality Spinal Fixation System Surgical Technique for additional information related to cleaning and disassembly of instruments. 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 the misuse or improper reprocessing. The Vitality System has not been validated to an automated cleaning process. 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, connectors, sliding parts, springs, etc.) to ensure smooth operation, throughout the intended range of motion.

6. If damage or wear is noted that may compromise the proper function of the instrument or instrument cases, do not use and contact customer service or your Zimmer Biomet Spine representative for a replacement.

LUBRICATION After cleaning and before sterilization, hinged, rotating, or articulating instruments should be lubricated with water soluble product (e.g., Instrument Milk or equivalent lubricant) intended for surgical instruments that must be sterilized. Some water-based instrument lubricants contain bacteriostatic agents which are beneficial. Manufacturer’s expiration dates should be adhered to for both stock and use-dilution concentrations. 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 (e.g., bone awl) 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. STORAGE AND HANDLING Re-usable instruments should be cleaned and sterilized after each use. Implants and instruments should be stored in the designated cases/trays specified by Zimmer Biomet Spine in a dry environment, away from oily or aggressive chemicals. Torque Limiting Drivers require periodic maintenance and must be returned to the manufacturer at the frequency indicated with the device. STERILIZATION The Vitality System implants and instruments must be sterilized prior to use in their specific case, tray, and lid. Remove all packaging materials prior to sterilization. Prior to sterilization, all instruments and implants must be loaded in the designed trays in the designated locations as indicated by the tray markings. Optional Vitality System instruments may be added to the dedicated universal space (with removable silicone mat) in select Vitality System trays under the guidelines described below. • Arrange all devices to ensure steam penetration to all instrument surfaces; do not stack instruments or place in close contact. 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) where applicable. Disinfection is only acceptable as a precursor to full sterilization for reusable surgical instruments.

4. Check instruments with long slender features (particularly rotating instruments) for distortion. 07.02199.001-en REV 05 2019-11

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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 of 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, ensure that the manufacturer’s maximum load is not exceeded. Steam (moist heat) is the recommended sterilization method for Zimmer Biomet screw implants and instruments. Ethylene oxide (EO), gas plasma and dry heat sterilization methods are not recommended for sterilization of Zimmer Biomet reusable instruments. Immediately re-sterilize all implant and instrument kits used in surgery. The following sterilization cycles have been laboratory validated by Zimmer Biomet Spine to provide a 10-6 sterility assurance level (SAL) for the Vital™ Spinal Fixation System, as well as loose instrumentation: Cycle #

1 2d 3d, e 4

Method

Steam (Full Cycle) Steam (Full Cycle) Steam (Full Cycle) Steam (Full Cycle)

Cycle Type

Sterilization Aesculap Exposure Number of Temperature Wrap Dry Time Wrapsa, b Dry Timec Timeb, c

Prevacuum

132°C (270°F)

4 minutes

2 times

30 45 minutes minutes

Prevacuum

134°C (273°F)

3 minutes

2 times

45 minutes

30 minutes

Prevacuum

134°C (273°F)

18 minutes

2 times

45 minutes

30 minutes

Prevacuum

135°C (275°F)

3 minutes

2 times

45 minutes

30 minutes

The following sterilization cycles have been laboratory validated by Zimmer Biomet Spine to provide a 10-6 sterility assurance level (SAL) for the Vitality® Spinal Fixation System (see table for applicable kit numbers): Cycle #

1 2d 3d, e 4

Method

Steam (Full Cycle) Steam (Full Cycle) Steam (Full Cycle) Steam (Full Cycle)

Exposure Number of Time Wrapsa, b

Sterilization Aesculap Wrap Dry Dry Timec Timeb, c

132°C (270°F)

4 minutes

2 times

30 85 minutes minutes

Prevacuum

134°C (273°F)

3 minutes

2 times

85 minutes

30 minutes

Prevacuum

134°C (273°F)

18 minutes

2 times

85 minutes

30 minutes

Prevacuum

135°C (275°F)

3 minutes

2 times

85 minutes

30 minutes

Cycle Type

Temperature

Prevacuum

a. Standard Medical Grade Steam Sterilization Wrap (Kimguard KC600 1-ply or equivalent) shall be used. b. An Aesculap container may be used in place of wrap. The total weight of the populated tray and Aesculap container must not exceed 11.4kg/25lbs for compliance with AAMI ST77. c. Dry Time is necessary to prevent wet packs. d. Cycles 2 and 3 are not considered by the Food and Drug Administration to be a standard sterilization cycle. 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 containers) that have been cleared by the Food and Drug Administration for the selected sterilization cycle specifications (time and temperature). e. For outside the United States, some non-U.S. Health Care Authorities may recommend sterilization according to Cycle 3 in order to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come in contact with the central nervous system.

Vitality Spinal Fixation System Kits Kit Number

Description

07.02136.401

Prep Instruments

07.02136.402

Manipulation Instruments

07.02136.403

5.5 – 8.5 Polyaxial Screws

07.02136.404

Transverse Connector, Reduction, Fixation

07.02136.405

Locking Instruments

07.02136.406

Complex Instruments 1

07.02136.407

Complex Instruments 2

07.02136.408

Complex Rods

07.02136.409

4.0 – 5.5 Polyaxial Screws

07.02136.410

6.0 – 7.5 Polyaxial Screws

07.02136.411

4.5 – 8.5 Reduction Screws

07.02136.412

Iliac Screws

07.02136.413

9.5 – 10.5 Polyaxial Screws

07.02136.414

4.5 – 6.5 Uniplanar Screws

07.02136.415

4.5 – 6.5 Uniplanar Reduction Screws

07.02136.416

4.0 – 7.5 Monoaxial Screws

07.02136.417

6.0 Rods

07.02136.418

Closed Iliac Screws

Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly. Note: Do not stack instrument kits directly on top of each other: Doing so may prevent the kits from fully drying. 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. POSTOPERATIVE MOBILIZATION Careful patient handling postoperatively 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 immobilization (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. MRI SAFETY INFORMATION The Vitality 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 Vitality 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:

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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. WARRANTY Please refer to the Product Purchase Agreement (or the like) in place with Zimmer Biomet Spine for further information about warranties and limitations of liability. 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, 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. 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. * These optional components are not approved in all regions.

© 2019 Zimmer Biomet Spine, Inc. All rights reserved. All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet Spine, Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet Spine, Inc.

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