ORTHOFIX Lonestar Cervical Stand Alone Ststem Instructions

ORTHOFIX Lonestar Cervical Stand Alone System

Description

The LONESTAR Cervical Stand Alone System is a stand-alone spacer system designed to provide biomechanical strength to a traditional or minimally invasive ACDF procedure with less
disruption of patient anatomy and preservation of the anatomical profile. The system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability.
The LONESTAR implant consists of a hybrid PEEK and titanium spacer along with titanium bone screws and a titanium cover plate. The spacers are designed with a zero degree anterior profile and are implanted using an anterior approach. The LONESTAR Cervical Stand Alone implants and instruments are provided non- sterile and will require thorough cleaning and sterilization prior to each use. The implants are not compatible with components or metal from any other manufacturer’s system

Indications for Use

The LONESTAR Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The LONESTAR Cervical Stand Alone System is used with autograft and/or allograft comprised of cancellous and/or cortico cancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the LONESTAR Cervical Stand Alone System in the cervical spine.

Contraindications

The LONESTAR Cervical Stand Alone System, as with other orthopedic implants, is contraindicated for use in patients with:

1. Active infections in which the use of an implant could preclude adequate and appropriate treatment of the infection.
2.  Rapidly progressive joint disease or bone absorption syndromes such as Paget’s disease, osteopenia, osteoporosis or osteomyelitis which may prevent adequate fixation.
3. Conditions that may place excessive stresses on bone and implants, such as severe obesity, pregnancy or degenerative diseases. The decision to use this system under such conditions must be made by the physician taking into account the risks versus the benefits to the patient.
4. Known or suspected metal allergies.
5. Prior fusion at the level to be treated.

Potential Adverse Events

Potential adverse events 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.
10. Dysphagia.

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. No implant can be expected to withstand the unsupported stresses of full weight bearing. The size, shape and condition of human bones are also contributing factors to the success of the surgery.
2. DO NOT USE DAMAGED IMPLANTS. 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. 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.
4. 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.
5. Do not re-sterilize single-use implants that come in contact with body fluids
6. Non-sterile; the LONESTAR Cervical Stand Alone implants and instruments are provided non-sterile, and therefore, must be thoroughly cleaned and sterilized before each use.
7. 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.
8. Based on dynamic testing results, the physician should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact the performance of the intervertebral body fusion device.
9. 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 LONESTAR Cervical Stand Alone 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 LONESTAR Cervical Stand Alone System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

Cleaning:
LONESTAR Cervical Stand Alone System 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 process described below. None of the instruments 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. Manufacturer’s 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. Softened tap water may be used to prepare the enzymatic detergents. Use of recommended temperatures is important for optimal performance of 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 device in cleaning solution and sonicate for 10 minutes.
4. 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.
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 a 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). Use of a syringe or water jet will improve 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.
   • a. 2 minute prewash with cold tap water
   • b. 1 minute prewash with hot tap water
   • c. 2 minutes detergent wash with hot tap water (64-66°C/146-150°F)
   • d. 1 minute hot tap water rinse
   • e. 2 minute thermal rinse with purified water (80-93°C/176-200°F)
   • f. 1 minute purified water rinse (64-66°C/146-150°F)
   • g. 7 to 30 minute 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.
Note: 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 Maintenance

• Only use torque limiting handles as intended. Never use torque limiting handles in the counterclockwise (CCW) direction to break loose a set screw or any other implant.
• 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.
• If a torque-limiting handle has been dropped, impacted or used incorrectly, recalibration should be performed.
• Torque-limiting handles require maintenance at 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

Sterilization in Orthofix Cases with Blue Wrap:
The LONESTAR Cervical Stand Alone System implants and instruments are supplied NONSTERILE. Prior to use, all implants and instruments should be placed in the appropriate Orthofix case which will be wrapped in a FDA cleared sterilization wrap and placed in the autoclave for sterilization by the hospital using one of the following recommended cycles:
Method: Steam

• Cycle: Gravity
• Temperature: 270°F (132°C)
• Exposure time: 15 minutes
• Drying time: 30 minutes
• Double wrapped

Method: Steam

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

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 LONESTAR Cervical Stand Alone System instruments and implants are provided in modular cases 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 in 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 complaints@orthofix.com.

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 LONESTAR Cervical Stand Alone 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

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