SKYHAWK Lateral Interbody Fusion System Instructions for Use

INSTRUCTIONS FOR USE

Important Information – Please Read Prior to Use

Orthofix Inc. 3451 Plano Parkway Lewisville, Texas 75056-9453 U.S.A. 214-937-2000 888-598-5700

0086

Medical Device Safety Service (MDSS) Schiffgraben 41 30175, Hannover Germany +49 511 6262 8630

English EN Device System Name:

SKYHAWK™ Lateral Interbody Fusion System Description: The SKYHAWK Lateral Interbody Fusion System consists of implants, trials, and instruments. The SKYHAWK Lateral Interbody Fusion System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F-2026 with Tantalum markers as described by ASTM F-560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, Tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The SKYHAWK Lateral Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device may be implanted using a lateral or anterolateral approach. The SKYHAWK Lateral Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use. Indications for Use: The SKYHAWK Lateral Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The SKYHAWK Lateral Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the SKYHAWK Lateral Interbody Fusion System. Contraindications: The SKYHAWK Lateral Interbody Fusion System, as with other orthopedic implants, is contraindicated for use in patients: 1) With active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection. 2) With rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis which may prevent adequate fixation. 3) With conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system in such conditions must be made by the physician taking into account the risks versus the benefits to the patient. 4) With known or suspected metal allergies. 5) With prior fusion at the level to be treated. Potential Adverse Effects: Potential adverse effects include, but are not limited to: 1) Failure of the device to provide adequate mechanical stability 2) Loss of fixation of the implant 3) Device component failure 4) Migration or bending of the device 5) Loss of bony alignment 6) Non-union 7) Fracture of bony structures 8) Resorption without incorporation of any bone graft utilized 9) Immunogenic response to the implant materials Note: As with any major surgical procedure, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications known to occur are: early or late infection, which may result in the need for additional surgeries, damage to blood vessels, spinal cord or peripheral nerves, pulmonary emboli, loss of sensory and/or motor function, impotence, permanent pain and/or deformity. Rarely, some complications may be fatal.

Warnings and Precautions: The surgeon should be aware of the following when using implants: 1) The correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape and design of the implant. The size and shape of the human bones present limiting restrictions of the size and strength of implants. No implant can be expected to withstand the unsupported stresses of the body full weight bearing. 2) The correct handling of the implant is extremely important. Implants should not be bent, notched or scratched. These operations can produce defects in surface finish and internal stress concentrations, which may become the focal point for eventual failure of the device. 3) DO NOT USE DAMAGED IMPLANTS. 4) Single Use Only – SKYHAWK Lateral Interbody Fusion System implants are SINGLE USE ONLY. No surgical implants should be reused. Any implant once used should be discarded. Even though the device appears undamaged, it may already have small defects and internal stress patterns that may lead to fatigue failure. Reuse could result in injury or require reoperation due to breakage or infection. 5) Non-sterile; the SKYHAWK Lateral Interbody Fusion System implants and instruments are provided non-sterile, and therefore must be thoroughly cleaned and sterilized before each use. 6) Postoperative care is important. The patient should be instructed in the limitations of the implant and should be cautioned regarding weight bearing and body stress on the device prior to secure bone healing. 7) Patients with previous surgery at the levels to be treated may have different clinical outcomes compared to those without a previous surgery. 8) The implantation of the intervertebral body fusion device should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient. MRI Compatibility Information: The SKYHAWK Lateral Interbody Fusion System has not been evaluated for safety and compatibility in the Magnetic Resonance (MR) environment. The SKYHAWK Lateral Interbody Fusion System has not been tested for heating or migration in the MR environment. Cleaning: Implants are provided clean but not sterile. Once an implant comes in contact with any human tissue or bodily fluid, it should not be re-sterilized and used. Please discard all contaminated implants. All instruments must be thoroughly cleaned prior to use and after each re-use of the instruments. Reprocess all instruments as soon as it is reasonably practical following use to prevent drying. Cleaning may be done using validated hospital methods or following the validated cleaning process described below. From Point of Use: Wherever possible, do not allow blood, debris, or body fluids to dry on instruments. For best results and to prolong the life of the surgical instrument, reprocess immediately after use. Preparation for Cleaning: 1. Any instruments with moving parts (i.e. knobs, triggers, hinges) should be separated and activated to open position to allow better access of the cleaning fluid to the difficult to clean areas. 2. None of these instruments require disassembly prior to cleaning. 3. Use a soft cloth or plastic bristle brush to remove any visible soil from the instruments. Cleaning Process: 1. Soak the SKYHAWK Lateral Interbody Fusion System instruments for a minimum of 10 minutes in sterile water prior to the manual or automated cleaning process. 2. Use a soft cloth or a soft plastic bristle brush to remove any visible soil from the instruments. Manual Cleaning Procedure: 1. Because none of the instruments can be disassembled, use a soft cloth and/or a soft plastic bristle brush to remove any visible soil from the outside and inside of the instrument. 2. Prepare Vesphene® IIse agent at the use-dilution recommended by label direction [1 ounce per gallon] as follows: Add 1 mL of Vesphene® IIse to 128.0 mL of potable tap water per manufacturer recommendations. 3. Bathe instruments in prepared room temperature solution as recommended by the detergent manufacturer. 4. Manually agitate instruments in Vesphene® solution for 15 minutes. 5. Scrub instruments with soft plastic bristle brush if visible soil is noted and use a soft plastic bristle brush or pipe cleaner long enough to reach the entire length of the interior lumen to remove the soil. 6. Rinse the instruments in USP <1231> purified water for 1.5 minutes. 7. Hang dry the device. 8. Visually inspect the instruments for visible soil. 9. If visible soil is noted, repeat the steps listed above.