Medtronic 79614210 Instructions for Use

Reusable Instruments used with

M708348B082E Rev. B

SOVEREIGN™ Spinal System

2017-01-13

IMPORTANT INFORMATION ON THE REUSABLE INSTRUMENTS USED WITH
SOVEREIGN™ SPINAL SYSTEM

PURPOSE

The instruments are intended for use in surgical procedures.

DESCRIPTION

Unless otherwise stated, instruments are made out of a variety of materials commonly used in orthopedic and neurological
procedures including stainless steel and silicone which meet available national or international standards specifications.

INTENDED USE

The instruments are intended to aid in the surgical implantation of SOVEREIGN™ Spinal System intervertebral body implants.
Do not implant the instruments.

WARNINGS

▪ Breakage, slippage, misuse, or mishandling of instruments may cause injury to the patient or operative personnel.
▪ Improper maintenance, handling, or poor cleaning procedures can render the instruments unsuitable for their intended

purpose, or even dangerous to the patient or surgical staff.

▪ It is important the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and

the forces applied while correcting the position of the instrumentation are not excessive, such that it might cause injury to
the patient.

▪ The methods of use of instruments are to be determined by the user's experience and training in surgical procedures. A

successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise the results.

▪ Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those

without a previous spinal surgery.

Medtronic does not and cannot warrant the use of the instruments nor any of the component parts upon which repairs have
been made or attempted except as performed by Medtronic or an authorized Medtronic repair representative.

PRECAUTIONS

▪ Excessive forces when using bending or fixation instruments can be dangerous especially where bone friability is

encountered during the operation.

▪ Any form of distortion or excessive wear on instruments may cause a malfunction likely to lead to serious patient injury.
▪ Regularly review the operational state of all instruments and, if necessary, make use of repair and replacement services.
▪ Do not use the instruments for any action for which they were not intended.
▪ To avoid injury, the instruments should be carefully examined for functionality or damage prior to use. A damaged

instrument should not be used. Additional back-up instruments should be available.

▪ The instruments should be carefully placed on trays, cleaned after each use, and stored in a dry environment.
▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the

successful use of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly
affect the results.

▪ Proper patient selection and operative care are critical to the success of the surgery and avoidance of injury during surgery.

Read and follow all other product information supplied by the manufacturer of the implants or the instruments.

▪ Special precautions are needed during pediatric use. Care should be taken when using instruments in pediatric patients,

since these patients can be more susceptible to the stresses involved in their use.

POSSIBLE ADVERSE EFFECTS

▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints.
▪ Infection if instruments are not properly cleaned and sterilized.

▪ Pain, discomfort, or abnormal sensations resulting from the presence of the device.
▪ Nerve damage due to surgical trauma.
▪ Dural leak in cases of excessive load application.
▪ Impingement of close vessels, nerves, and organs by slippage or misplacement of the instrument.
▪ Damage due to spontaneous release of clamping devices or spring mechanisms of certain instruments.
▪ Cutting of skin or gloves of operating staff.
▪ Bony fracture in cases of deformed spine or weak bone.
▪ Tissue damage to the patient, physical injury to operating staff, and/or increased operating time that may result from the

disassembly of multi-component instruments occurring during surgery.

Physician note: although the physician is the learned intermediary between the company and patient, the important medical
information given in this document should be conveyed to the patient.

For US audiences only
Caution: federal law (USA) restricts these devices to sale by or on the order of a physician.
These devices should be used only by physicians familiar with the devices, their intended use, any additional instrumentation,

and any available surgical techniques.

PACKAGING

Instruments used with SOVEREIGN™ Spinal System are supplied non-sterile.
Packages should be intact upon receipt. All sets should be carefully checked for completeness and all components should be

carefully checked for signs of damage prior to use. Damaged packages or products should not be used and should be returned
to Medtronic.

Remove all packaging material prior to sterilization. Only sterile implants and instruments should be used in surgery. Always
immediately re-sterilize all instruments used in surgery. Instruments should be thoroughly cleaned prior to re-sterilization. This
process must be performed before handling, or before returning product to Medtronic.

EXAMINATION

Instruments must always be examined by the user prior to surgery.
Examination should be thorough, and must include a visual and functional inspection of the working surfaces, pivots, racks,

spring or torsional operation, cleanliness of location holes or cannulations, and the presence of any cracks, bending, bruising or
distortion, and that all components of the instruments are complete.

Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or otherwise not functional.

Visual Inspection

Make certain of the following:

▪ Laser etchings, engravings, and other markings are legible.
▪ No cracks are present in instrument handles or any part of the instruments.
▪ Discoloration, stains, or rust do not exist on the instruments. If present, attempt to clean in accordance with the Manual

Cleaning section of this document.

▪ There is no handle/shaft separation, and the handle-to-shaft connection is secure.
▪ No cuts or gouges in silicone are present.
▪ There is no damage to the working ends or tips of the instruments. The working ends should be free of cracks, sharp edged

gouges, and other damage.

▪ There is no damage to threads present on an instrument.
▪ All parts of an instrument are present and free of damage.
▪ Mating ends are free of damage (nicks, gouges, bends, etc.) that would interfere with the mating function.
▪ Cannulated instruments with a guide wire or other insertion tool are visually checked.

Functional Inspection

Make certain of the following:

▪ The parts intended to move do so freely without sticking, binding, or grinding.
▪ Instruments function as intended with the appropriate mating parts.
▪ Tips meet when appropriate.

REPROCESSING - GENERAL CONSIDERATIONS

It is the purpose of this section to provide cleaning, disassembly, and sterilization procedures for the instruments used with
SOVEREIGN™ Spinal System. First, it is important to outline the terminology used in this section and its significance in
reprocessing.

Cleaning is the removal of organic soil. Effective cleaning:

▪ Minimizes the organic soil transfer from one patient to another.
▪ Prevents accumulation of residual soil throughout the product’s use life.
▪ Allows for successful follow up sterilization. Adequate reprocessing is contingent upon the thoroughness of cleaning.

Cleaning is the initial step and sterilization occurs later in reprocessing and is intended to kill microorganisms to reduce the
likelihood of transmission and possibilities of infection. To ensure acceptable reprocessing, there should be no delay between
the steps in this document.

Bloodborne Pathogens

Universal precautions for handling these devices after use should be observed by all hospital personnel according to OSHA
Standard 29 CFR 1910.1030 concerning occupational exposure to bloodborne pathogens.

Thorough Cleaning of Instruments

It is critical that these devices are thoroughly cleaned after each use by following the cleaning steps listed in this document.
Ineffective or incomplete cleaning can hinder sterilization activities.

Automated Cleaning

A fully automated washer/disinfector cycle is not recommended as the sole cleaning method for these devices. Manual cleaning
of these devices, after disassembly where specified, is required.

Manual Cleaning

Disinfection agents such as sanitizing and chemical solutions act to reduce microbes on device surfaces, but may not act as
cleaners. Other types of soaps or detergents may not clean these devices to an appropriate level of cleanliness. Enzymatic
cleaning agents are recommended. This type of cleaner has been shown to effectively remove organic soils, such as blood,
from these devices. The cleaning instructions for these devices have been validated by Medtronic using an enzymatic cleaner.

Cleaning Agents and Cleaning Tools

The following cleaning agents, solutions, or tools should not be used:

▪ Saline solution.
▪ Alkaline cleaning agents.
▪ Solutions containing chlorine (e.g., bleach) or aldehydes (e.g., glutaraldehyde).
▪ Formalin, mercury, chlorides, bromides, iodides, or Ringer's solution.
▪ Metal brushes or scouring pads.

The use of neutral pH enzymatic cleaners and soft bristled brushes and soft pipe cleaners are recommended.

Cleaning and Rinsing Water

Tap water can be used to clean these devices. De-ionized water should be used for the final rinse step to prevent mineral
deposits on the device surfaces.

Use of Mineral Oil or Silicone-Based Lubricants

These types of lubricants should never be used on these devices as they may not be removed by these cleaning instructions.
The lubricants may coat microorganisms, prevent direct contact of steam with the device surfaces, and hinder sterilization.

MANUAL CLEANING INSTRUCTIONS

Proper Handling after Use

Do not allow these devices to dry after use and prior to cleaning. Cleaning and subsequent sterilization may be hindered when
blood or bloody solutions are allowed to dry on the devices.

Cleaning Instructions - Point of Use

1. Remove all visible soil from the devices using non-shedding wipes.

2. Place the devices in a tray of de-ionized water or cover with damp towels. Instruments should be cleaned within 30 minutes

of use to minimize the drying.

3. Immediately transport the tray containing the covered devices to a work area dedicated to further reprocessing.

Cleaning and Disassembly Instructions for Instruments Requiring Disassembly Prior to Cleaning

The following instruments must be disassembled for effective cleaning:

▪ SOVEREIGN™ Inserter assembly (P/Ns 7967028, 7967085, 7967079, 7967080, 7967081)
▪ SOVEREIGN™ Oblique Inserter assembly (P/Ns 7967028, 7967085, 7967095, 7967096, 7967097)
▪ SOVEREIGN™ Oblique Remover assembly (P/Ns 7967028, 7967085, 7967042, 7967043, 7967044)

1. Hold the inserter sleeve and turn the knob clockwise until the inserter shaft is removed.

2. Press the locking button on the knob.