Medtronic 6973080 Instructions for Use

PRESTIGE LP™ Reusable

M708348B872E Rev. A

Instruments

2018-12-10

IMPORTANT INFORMATION FOR THE PRESTIGE LP™ REUSABLE INSTRUMENTS

DESCRIPTION

The PRESTIGE LP™ reusable instruments are made out of a variety of materials commonly used in orthopedic and
neurological procedures which meet available national or international standards specifications.

INTENDED USE

The PRESTIGE LP™ reusable instruments are intended for the surgical implantation of the PRESTIGE LP™ Cervical Disc.
Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.

Do not re-use or re-process devices labeled as single use devices. Re-use or re-processing of single use devices may
compromise the structural integrity and the intended function of the device which could result in patient injury.

DO NOT IMPLANT THE INSTRUMENTS.

If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic Customer Service for
instructions. Any available surgical techniques will be provided at no charge.

Medtronic does not and cannot warrant the use of these 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. Implied warranties
of merchantability and fitness for a particular purpose or use are specifically excluded.

WARNINGS

▪ Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to the patient or

operative personnel.

▪ Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its 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 is 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 surgery.

PRECAUTIONS

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 this instrument for any action for which it was not intended.

To avoid injury, the instrument should be carefully examined prior to use for functionality or damage prior to use. A
damaged instrument should not be used. Additional back-up instruments should be available.

▪ These 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 utilization 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.

▪ Some surgeries require the use of instruments which incorporate a measuring function. Ensure these are not worn and any

surface engravings are clearly visible.

POTENTIAL 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 instrument.
▪ 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 the 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

The PRESTIGE LP™ reusable instruments are supplied non-sterile. Packages for non-sterile components 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 cleaning and sterilization. Only sterile instruments should be used in surgery.
Instruments should be thoroughly cleaned prior to re-sterilization. Always immediately clean and re-sterilize all instruments used
in surgery. This process must be performed before handling, or before returning product to Medtronic.

EXAMINATION

Instruments must always be examined by the user prior to use in surgery. Examination should be thorough, and should take into
account 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 all components of the
instrument are complete.

Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or otherwise
nonfunctional.

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 instrument.
▪ Discoloration, stains, or rust do not exist on the instrument. If present, attempt to remove in accordance with the cleaning

instructions provided in the Processing and Reprocessing 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 (cuts, tears, etc.) to insulation.
▪ There is no damage to the working ends or tips of the instrument. The working ends should be free of cracks, sharp edged

gouges, and other damage. When applicable, the working ends should be sharp.

▪ There is no damage to threads present on an instrument.
▪ All parts of an instrument are present and free of damage. Examples of parts that may be missing, loose, or damaged

include set screws, springs, curved springs, pins, and prongs.

▪ 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 will do so freely, without sticking, binding, or grinding.
▪ Springs return the handle of the instrument to its original position.
▪ Retention tabs hold appropriate mating parts and are not damaged.
▪ The instrument will function as intended with the appropriate mating parts.
▪ Sharp edges are sharp to the touch and are not dull, have no nicks, or any other damage.
▪ Tips meet when appropriate.

Processing and Reprocessing Instructions - General Considerations

It is the purpose of this document to provide cleaning, disassembly, and sterilization procedures for the PRESTIGE LP™
Reusable Instruments. First, it is important to outline the terminology used in this document and its significance in reprocessing.

Cleaning is the removal of organic soil. Effective cleaning: