ORTHOFIX AW-79-9901 Connector System Instruction Manual

ORTHOFIX AW-79-9901 Connector System

Description

The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from Titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g Firebird Spinal Fixation/Phoenix MIS Spinal Fixation System, Spinal Fixation System, Centurion POCT System, Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

Indications for Use

When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ – T3): The Connector System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced-stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium): The Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:

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

When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

Contraindications

Contraindications include, but are not limited to:

1. Morbid obesity
2. Mental Illness
3. Alcoholism or drug abuse
4. Pregnancy
5. Metal sensitivity/allergies
6. Severe osteopenia
7. Patients unwilling or unable to follow post-operative care instructions
8. Use of the offset connectors for fixation to the ilium is contraindicated when the sacrum is absent or insufficient for implantation of pedicle screws at the S1 or S2 spinal level.
9. Any circumstances not listed under the heading indications.

Potential Adverse Events

Potential adverse events include, but are not limited to:

1. Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)
2. Proximal or distal junctional kyphosis
3. Pancreatitis
4. Pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also oc-cur in pediatric patients, and pediatric patients may be at increased risk for device-related injury because of their smaller stature.
5. Device component fracture
6. Loss of fixation
7. Non-union
8. Fracture of the vertebra
9. Neurological injury
10. Vascular or visceral injury
11. Early or late loosening of any or all of the components
12. Disassembly and/or bending of any or all components
13. Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, straining, tumor formation, and/or auto-immune disease
14. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain
15. Post-operative change in spinal curvature, loss of correction, height, and/or reduction
16. Infection
17. Pain, discomfort, or abnormal sensations due to the presence of the device
18. Hemorrhage
19. Cessation of any potential growth of the operated portion of the spine
20. Death

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, perma-nent pain and/or deformity. Rarely, some complications may be fatal.

Warnings and Precautions

1. The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels.
2. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection of placement of the implants are important considerations in the successful utilization of the system in pediatric patients.
3. The selection of proper size, shape and design of the implant for each patient is crucial to the safe use of this device in pediatric patients.
4. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
5. Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
6. 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.
7. 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.
8. Non-sterile; the connectors, and instruments are sold non-sterile, and therefore must be sterilized before use.
9. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material should be used.
10. Failure to achieve arthrodesis will result in eventual loosening and failure of the device construct.
11. Excessive torque applied to the screws may strip the threads in the bone.
12. The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of spinal systems.
13. Based on fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system.
14. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the titanium alloy or cobalt chrome alloy components of this system with implants of other material composition or components from different manufacturers unless specifically stated.
15. The safety, efficacy and performance of the system have been established for conditions in which the system is used as intended and when used as identified in the Indications for Use. Performance of the system has not been evaluated for use that is contrary to the Intended Use, Indications for Use or for use that in contraindicated. Failure to use the system as indicated could detrimentally affect the performance of its components.
16. Other adverse effects related to pedicle screw fixation, such as rod bending, breakage, or loosening, may also occur in pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their small stature.
17. The correct handling of the implant is extremely important. Implants should not be excessively or repeatedly bent, notched or scratched. These operations can produce defects in surface finish and internal stress concentrations, which may become the focal point for the eventual failure of the device.

MRI Compatibility Information

Non-clinical testing and MRI simulations that included in-vivo, clinically relevant modeling were performed to evaluate the entire family of the Pedicle Screw System. Non-clinical testing demonstrated that the entire family of the system is MR Conditional. A patient with an implant from this family can be scanned safely in an MR system under the following conditions:

• The static magnetic field of 1.5-Tesla or 3-Tesla, only
• Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
• Maximum MR system reported whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode

Under the scan conditions defined, an implant from the Pedicle Screw System is expected to produce a maximum temperature rise of 3.0°C after 15 minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by an implant from the Pedicle Screw System extends approximately 8-mm from this device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.

Cleaning

Connector System instruments and 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 vali-dated 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 the 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 risks.

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. The manufacturer’s instructions for the 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. The 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 the 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 the 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). 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.
6. 2-minute prewash with cold tap water
7. 1-minute prewash with hot tap water
8. 2-minute detergent wash with hot tap water (64-66°C/146-150°F)
9. 1-minute hot tap water rinse
10. 2-minute thermal rinse with purified water (80-93°C/176-200°F)
11. 1 minute purified water rinse (64-66°C/146-150°F)
12. 7 to 30-minute hot air dry (116°C/240°F)
13. Inspect the instruments for visible soil.
14. 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 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 the end of life. Orthofix reusable instruments have reached the 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 the bone and/or tissue (e.g. tap, rasp, curette, rongeur)
3. when any of the cutting surfaces show signs of wear such as nicks, abrasions or otherwise dulled cutting surfaces.
4. 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.
5. Do not use instruments that reached the End of Life. Discard End of Life instruments per your hospital procedure or return them to Orthofix for disposal.

Sterilization

Sterilization in Orthofix Cases with Blue Wrap
The Connector System instruments and/or implants are supplied NON-STERILE. Prior to use, all [instruments and/or implants] 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

or:

• Method: Steam
• Cycle: Privacy
• Temperature: 270°F (132°C)
• Preconditioning: Per Manufacturer’s Settings
• 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’s 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: Privacy
• Temperature: 270°F (132°C)
• Preconditioning: Per manufacturer’s settings
• Exposure time: 4 minutes
• Drying time: 30 minutes

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.

Patient Information

The temporary internal fixation devices used in your recent spinal surgery are metallic implants that attach to the bone and aid in the healing of bone grafts. These implants have been shown to be valuable aids to surgeons in the treatment of bony fusions. These devices do not have the capabilities of living bone. Intact living bone is self-repairing, flexible, and occasionally breaks and/or degrades. The anatomy of the human body places a size limitation on any artificial fixation device used in surgery. The maximum size limitation increases the changes of mechanical complications of loosening, bending, or breaking of devices. Any of these complications could result in the need for additional surgery. Accordingly, it is very important that you follow the recommendations of your physician. Use braces as instructed. By following these instructions, you can increase your chances of a successful result and reduce your risk of injury and/or additional surgery.

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 Connector System instruments and/or implants are provided in a modular case/modular caddy 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/or 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 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 Connector System are not formulated 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 these devices to sale by or on the order of a physician.

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician

• See Instructions for Use
• Orthofix.com/IFU
• Catalog Number
• Provided Non-Sterile
• Lot Number
• Single-Use Only Do Not Reuse
• Manufacturer
• Authorized Representative
• Serial Number
• MR Conditional

References

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

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