Medtronic 7480741T Instructions for Use

Medtronic Non-Sterile General

M708348B597E Rev. A

Instruments which can be used with
Bone Cement

2016-09-20

Important Information for Medtronic Non-Sterile Instruments

DESCRIPTION

Medtronic non-sterile general instruments that can be used with bone cement are made out of a variety of materials commonly
used in orthopedic procedures which meet applicable national or international standard specifications. These instruments may
be used with or without bone cement in certain procedures. These instruments can be reprocessed and reused if they have not
been used with bone cement or have not come into direct contact with bone cement. These instruments cannot be reprocessed,
or reused when they have been used with, or have come in direct contact with bone cement.

INTENDED USE

These orthopedic manual surgical instruments are intended to perform a variety of functions (e.g. manipulate bone, assist with
other medical devices/instruments, etc.) in surgical procedures. Additionally, these instruments may incorporate a measuring
function, which has uses as described on the label of the instruments.

When coming in direct contact with bone cement these instruments are NOT allowed to be reprocessed or reused. When used
in the absence of cement, these instruments may be reprocessed and reused.

DO NOT IMPLANT THE INSTRUMENTS.

Medtronic does not and cannot warrant the use of this instrument 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

▪ These instruments should never be reused or reprocessed after they have been in direct contact with bone cement and the

bone cement is in or on the instrument.

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.

▪ The surgeon should use extreme caution when working in close proximity to vital organs, nerves or vessels. In addition,

excessive force should not be used when positioning the instruments or implant, since it could cause injury to the patient.

PRECAUTIONS

▪ Excessive force applied by instruments to implants can dislodge devices.
▪ Never expose instruments to temperatures in excess of 135 °C (275°F). This level of heating may modify the physical

characteristics. If uncertain if the instruments were exposed to temperatures in excess of 135°C (275°F), carefully inspect
the instruments to ensure they still function as intended.

▪ Extreme care should be taken to ensure this instrument is in good working order. During the procedure, successful

utilization of this instrument is extremely important. Instruments should not be bent, clogged or damaged in any way.
Misuse of instruments, resulting in corrosion, “freezing-up”, scratching, loosening, bending, or fracture of any or all sections
of an instrument may inhibit or prevent proper function.

▪ The instruments should be discarded after direct contact with bone cement and the bone cement is in or on the instrument.

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

▪ Regularly review the operational state of all instruments and, if necessary, contact Medtronic or an authorized Medtronic

repair representative. To avoid injury, the instrument 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.

▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the

successful use of the instruments by the surgeon. 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.

▪ Care should be taken when using instruments in pediatric patients, since these patients can be more susceptible to the

stresses required in their use.

▪ Ensure instruments with a measuring function are not worn and any surface engravings are clearly visible.

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 the 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.

▪ Inability to use these instruments if the bone cement has disabled the proper function and the instruments are not disposed

of.

▪ 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.

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 (U.S.) law restricts these devices to sale by or on the order of a physician only.
This device should be used only by physicians familiar with the device, its intended use, any additional instrumentation, and any

available surgical techniques.

PACKAGING

Packages for instruments should be intact upon receipt. All devices should be checked for completeness and all instruments
should be checked for signs of damage prior to use. Damaged packages or products should not be used and should be
returned to Medtronic.

EXAMINATION

Instruments must always be examined by the user pre/post cleaning and 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 bone cement, cracks, bending, deformation, or distortion, and that all
components are present. Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or
otherwise non-functional.

Visual Inspection

Ensure the following:

▪ Laser markings, engravings, and other markings are legible.
▪ No bone cement present anywhere on or in the device.
▪ No cracks, deformation, or distortion are present.
▪ No cracks are present in instrument handles or any part of the instrument.
▪ No discoloration, corrosion, stains, or rust are present. If present, wipe clean in accordance with the instructions in the

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, silicone brackets, or instrument handles are present.
▪ There is no damage (cuts, tears, etc.) to the insulation.
▪ There is no damage to the working ends or tips. The working end should be free of cracks, gouges, and other damage.

When applicable, the working end should be sharp.

▪ There is no damage to instrument threads.
▪ All parts are present and free of damage and deterioration. 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

As applicable, ensure the following:

▪ Any moving parts move 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.
▪ Ball detents will hold mating parts and are free from damage.
▪ Sharp edges are sharp to the touch and are not dull, have no nicks, or any other damage.
▪ Tips meet when appropriate.
▪ Ratcheting mechanisms are functional. This includes handles, latches, and other mechanisms. All teeth should be present

and functional.

▪ Driver tips are not worn beyond functional use. If necessary, mate the instrument with the appropriate part.

REPROCESSING - GENERAL CONSIDERATIONS

Cleaning is the removal of organic soil. Effective cleaning:

▪ Avoids organic soil transfer from one patient to another.
▪ Allows for successful follow up sterilization. Adequate reprocessing is contingent upon the thoroughness of cleaning.

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

Instruments may be safely and effectively processed using manual or a combination of manual and automated washer­disinfector (enzymatic or alkaline) cleaning procedures outlined in this document.

The processor should comply with local laws and ordinances in countries where processing requirements are more stringent
than those detailed in this document.

Bloodborne Pathogens

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

Cleaning Agents and Cleaning Tools

The use of neutral detergents, enzymatic cleaners (7.0 – 8.0 pH), alkaline cleaning agents (8.0 – 11.0 pH), soft bristled brushes,
and soft pipe cleaners are recommended.

Note: alkaline cleaning agents may require neutralization following cleaning. Refer to manufacturer’s instructions to determine if
neutralization is required, and to follow manufacturer’s instructions for neutralization. It is critical that alkaline cleaning solutions
be properly neutralized and rinsed from instruments.

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

▪ Saline solution.
▪ 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.
▪ High alkaline cleaning agents (>11.0 pH).

Cleaning and Rinsing Water

If available, softened tap water should be used. Critical water should be used for the final rinse step to prevent mineral deposits
on surfaces (de-ionized is recommended). One or more of the following processes may be used to treat water defined as critical
water: ultra-filter (UF), reverse osmosis (RO), de-ionized (DI), or equivalent. Use of hard water should be avoided.

Use of Mineral Oil or Silicone-Based Lubricants

Mineral Oil- or silicone-based lubricants should not be used as they may not be removed by these cleaning instructions. These
types of lubricants may coat microorganisms, prevent direct contact of steam with instrument surfaces, and hinder sterilization.

Reprocessing Warnings/Cautions

▪ These instruments should never be reused or reprocessed after they have been in direct contact with bone cement and the

bone cement is in or on the instruments.

▪ Do not allow soiled instruments 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 instruments.

▪ Medtronic reusable instruments are considered critical devices (i.e. critical contact) and must be thoroughly cleaned, then

sterilized prior to initial use, or in adherence to these reprocessing instructions before reuse.

▪ Soiled or used instruments should not be loaded into the dedicated Medtronic Transportation/Sterilization Cassettes for

cleaning in an automated washer- disinfector. Soiled instruments must be processed separately from Medtronic
Transportation/Sterilization Cassettes.

▪ Universal precautions should be observed by all health care facility personnel that work with contaminated or potentially

contaminated instruments. Caution should be exercised when handling instruments with sharp points or cutting edges.

▪ Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially

contaminated materials, devices and equipment. PPE includes gowns, masks, goggles, face shields, gloves, and shoe
covers.

▪ Do not place heavy instruments on top of delicate instruments.