ORTHOFIX SKYHAWK Lateral Plate System Instructions

ORTHOFIX SKYHAWK Lateral Plate System

Description

The SKYHAWK Lateral Plate System consists of an assortment of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates and bone screws. The plates attach by means of Screws to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The system implants and instruments are provided non-sterile. They require sterilization prior to use

Indications for Use

The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications:

1. Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis.
3. Spinal stenosis.
4. Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis).
5. Tumor.
6. Pseudoarthrosis.
7. Failed previous fusion.
8. Trauma (i.e., fracture or dislocation).

Contraindications

The SKYHAWK Lateral Plate System is contraindicated in patients with a systemic infection, with a local inflammation at the bone site, or with rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis, or osteomyelitis. Do not use this system in patients with known or suspected metal allergies. Use of the system is also contraindicated in patients with any other medical, surgical or psychological condition that would preclude potential benefits of internal fixation surgery such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by another disease, elevation of white blood cells or a marked shift in white blood cell differential count.

Potential Adverse Events

Potential adverse events include, but are not limited to

1. Early or late loosening of any or all of the components.
2. Disassembly, bending, and/or breakage of any or all of the components.
3. Foreign body (allergic) reaction to implants, debris, corrosion products, and graft material, including metallosis, straining, tumor formation, and/or auto-immune disease.
4. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causes skin penetration, irritation, and/or pain.
5. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
6. Infection.
7. Vertebral body fracture at, above, or below the level of surgery.
8. Loss of neurological function, including paralysis (complete or incomplete).
9. Non-union, delayed union.
10. Pain, discomfort, or abnormal sensations due to the presence of the device.
11. Hemorrhage.
12. Cessation of any potential growth of the operated portion of the spine.
13. Death.

Note: Additional surgery may be necessary to correct some of these anticipated adverse events.

Warnings and Precautions
The surgeon should be aware of the following when using implants:

1. The SKYHAWK Lateral Plate System is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
2. Always orient the plate along the midline of the spine.
3. To optimize bony union, perform an anterior microdiscectomy or corpectomy as indicated.
4. To facilitate fusion, a sufficient quantity of autologous bone should be used.
5. Excessive torque applied to the screws when seating the plate may strip the threads in the bone.
6. Failure to achieve arthrodesis will result in eventual loosening and failure of the device construct.
7. DO NOT USE DAMAGED IMPLANTS.
8. Non-sterile; the system implants and instruments are provided non-sterile, and therefore must be sterilized before each use.
9. The health care provider must thoroughly clean the instruments prior to steam sterilization.
10. Single-use only. Reuse of devices labeled as single-use (e.g. implants, drills, tacks, trial rods) could result in injury or reoperation due to breakage or infection
11. All implants are intended for SINGLE USE ONLY. Any used implant should be discarded. Even though the device may appear undamaged, it may have small defects and internal stress patterns that may lead to fatigue failure.
12. Do not combine system implantable components with those from any other system or manufacturer.
13. Do not combine implants of dissimilar metals, as it may result in galvanic corrosion.

MRI Compatibility Information

• The SKYHAWK Lateral Plate System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR  environment. The safety of the SKYHAWK Lateral Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

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 or used. Please discard all contaminated implants.
• All instruments must be thoroughly cleaned after each use. Cleaning may be done using validated hospital methods or following the validated cleaning processes described below.
• None of the instruments in the system require disassembly prior to cleaning.

From Point of Use

Whenever 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.

1. Remove excess body fluids and tissue from instruments with a disposable, non-shedding wipe. Place instruments in a basin of purified 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.
2. 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.
3. Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk.

Note: Soaking in proteolytic enzymatic detergents or other pre-cleaning solutions facilitates cleaning, especially in instruments with complex features and hard-to-reach areas (e.g. cannulated and tubular designs, etc.). These enzymatic detergents as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based materials from drying on instruments. Manufacturers’ instructions for preparation and use of these solutions should be explicitly followed.

Preparation for Cleaning

1. All instruments with moving parts (e.g., knobs, triggers, hinges) should be placed in the open position to allow access of the cleaning fluid to areas that are difficult to clean.
2. Soak the instruments for a minimum of 10 minutes in purified water prior to the manual or automated cleaning process.
3. Use a soft cloth or a soft plastic bristle brush to remove any visible soil from the instruments prior to manual or automated cleaning. Use a soft plastic bristle brush or a pipe cleaner to remove soil from any inner lumens. You can also use a syringe (if appropriate) for hard-to-reach areas.
4. Enzymatic detergent should be used for manual and automated cleaning. All enzymatic detergents should be prepared at the use dilution and temperature recommended by the manufacturer.
5. Softened tap water may be used to prepare the enzymatic detergents. Use of recommended temperatures is important for the optimal performance of the enzymatic detergent.

Manual Cleaning

1. Completely submerge instruments in an enzymatic detergent and allow to soak for 20 minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush).
2. Remove the instruments from the enzymatic detergent and rinse in tap water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult to reach areas.
3. Place prepared cleaning solution in a sonication unit. Completely submerge the device in cleaning solution and sonicate for 10 minutes.
4. Rinse the 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.
5. Repeat the sonication and rinse steps above.
6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe.
7. Inspect the instruments for visible soil.
8. If visible soil is noted, repeat the steps listed above.

Automated Cleaning

1. Completely submerge the instruments in an enzymatic detergent and allow to soak and sonicate for 10 minutes each. Use soft nylon bristled brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft nylon bristled brush (i.e. pipe cleaner). The use of a syringe or water jet will improve the flushing of difficult-to-reach areas and closely mated surfaces.
2. Remove instruments from the cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult to reach areas.
3. Place instruments in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle.
4. Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer
5. The following minimum parameters are essential for thorough cleaning.
   • 2-minute prewash with cold tap water
   • 1-minute prewash with hot tap water
   • 2-minute detergent wash with hot tap water (64-66°C/146-150 F)
   • 1-minute hot tap water rinse
   • 2-minute thermal rinse with purified water (80-93°/176-200°P)
   • 1 minute purified water rinse (64-66°C/146-150°F)
   • 7 to 30 minutes hot air dry (116°C/240°F).
6. Inspect the instruments for visible soil.
7. If visible soil is noted, repeat the above-listed steps until no visible soil is noted.

Note

• Certain cleaning solutions such as those containing caustic soda, formalin, glutaraldehyde, bleach, and/or other alkaline cleaners may damage instruments. These solutions should not be used.
• Visually inspect instruments after cleaning and prior to each use. Discard or return to Orthofix any instruments that are broken, discolored, corroded, have cracked components, pits, gouges, or are otherwise found defective. Do not use defective instruments.

Torque Limiting Instrument Use

• Never use torque-limiting drivers in the counter-clockwise (CCW) direction to loosen a fastener
• Only use torque limiting handle as intended per the operative technique
• Never impact on torque limiting handles or use as an impacting device on other devices
• Never use a torque limiting handle as a prying tool

Torque Limiting Instrument Maintenance

• If a torque-limiting handle has been dropped, impacted or used incorrectly, return to Orthofix.
• Torque-limiting handles require maintenance at a minimum, every three years or per your service agreement. Please return your torque limiting handles to Orthofix for required maintenance.

Instrument End of Life Determination

Do not reuse Single Use instruments. Visually inspect the reusable instruments to determine if the instrument has reached end of life. Orthofix reusable instruments have reached End of Life when:

1. Instruments show signs of damage such as binding, bending, breakage, overt signs of wear and/or any other conditions which may impact the devices safe and effective use.
2. Instruments intended for cutting bone and/or tissue (e.g. tap, rasp, curette, rongeur) – when any of the cutting surfaces show signs of wear such as nicks, abrasions or otherwise dulled cutting surfaces.
3. Instruments that interface with other devices (e.g. implants, instruments, handles) – when the mating feature binds, fails to attach or fails to hold the device securely. The instrument function should be verified prior to each use.
4. Do not use instruments which reached End of Life. Discard End of Life instruments per your hospital procedure or return to Orthofix for disposal.

Sterilization

The SKYHAWK Lateral Plate System implants and instruments are supplied NON- STERILE. Prior to use, all implants and instruments should be placed in the instrument/implant case which will be either wrapped in an FDA-cleared sterilization wrap or placed in a rigid sterilization container and placed in the autoclave for sterilization by the hospital using one of the following recommended cycles:

Sterilization in Orthofix Cases with Blue Wrap

• Method: Steam
• Cycle: Gravity
• Temperature: 270°F (132°C)
• Exposure time: 15 minutes
• Drying time: 30 minutes Double wrapped (FDA cleared wrap recommended)

or

• Method: Steam
• Cycle: Prevac
• Temperature: 270°F (132°C)
• Exposure time: 4 minutes
• Drying time: 30 minutes Double wrapped FDA cleared wrap recommended)

Sterilization in Rigid Sterilization Containers

When using rigid sterilization containers, clean, inspect and prepare the rigid sterilization container according to the manufacturer instructions.

Select the appropriate rigid sterilization container with either a filtered or solid bottom to properly enclose the Orthofix case (recommended 23¼” long x 11¼” wide container). The following sterilization cycle has been validated:

• Method: Steam
• Cycle: Prevac
• Temperature: 270°F (132°C)
• Exposure time: 4 minutes
• Drying time: 30 minutes

Note: Rigid sterilization containers with solid bottoms cannot be used in gravity steam cycles.

Validation and routine monitoring should be performed per ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Other cycles may be used as long as they comply with the above practices and provide a sterility assurance level of 10-6.

Packaging

Packages for each of the components should be intact upon receipt. If a consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked for damage prior to use. Damaged packages or products should not be used and should be returned to Orthofix. The SKYHAWK Lateral Plate System instruments and implants are provided in a modular case specifically intended to contain and organize the system’s components. The system’s instruments are organized into trays within each modular case for easy retrieval during surgery. These trays also provide protection to the system components during shipping. Additionally, individual instruments and implants are provided in sealed poly bags with individual product labels.

Product Complaints

Any Health Care Professional (e.g., customer or user of this system of products) who has any complaints or who has experienced any dissatisfaction with the product quality, identity, durability, reliability, safety, effectiveness, and/or performance, should notify Orthofix Inc., 3451 Plano Parkway, Lewisville, TX 75056, USA, by telephone at 1-214-937-3199 or 1-888-298-5700 or by e-mail at [email protected]

Further information: A recommended operative technique for the use of this system is available upon request from Orthofix at the phone numbers provided above.

Latex Information

The implants, instruments and/or packaging material for the SKYHAWK Lateral Plate System are not formulated with and do not contain natural rubber. The term “natural rubber” includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Orthofix Inc

• ADRESS: 3451 Plano Parkway Lewisville, Texas 75056-9453 U.S.A.
• Tel: 1-214-937-3199
• 1-888-298-5700
• www.orthofix.com

Australian Sponsor

• ADDRESS: Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney, NSW 2000 Australia

Medical Device Safety

• Address: Service (MDSS) Schiffgraben 41 30175 Hannover Germany
• www.mdss.com

AW-24-9901 Rev. AG
SH-2201 © Orthofix US LLC 07/2022

References

• Instructions for Use - Orthofix
• EU Authorized Representative Services For Medical Devices
• Orthofix - Medical Devices & Solutions

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