Medtronic A6006 Instructions for Use

FOR US AUDIENCES ONLY

0380035E Rev. G

Medtronic Reusable Instruments and
Accessories

2021-01-26

IMPORTANT INFORMATION FOR MEDTRONIC REUSABLE INSTRUMENTS AND
ACCESSORIES

DESCRIPTION

Reusable instruments are manufactured from a variety of materials commonly used in orthopedic and neurological procedures,
which meet applicable national and/or international standards. These instruments may be shipped in Medtronic Transportation/
Sterilization Cassettes. The Medtronic Transportation/Sterilization Cassettes are designed to be used in conjunction with a
legally marketed, validated, and FDA-cleared sterilization wrap to allow steam sterilization of non-sterile devices.

Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a
variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize
Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended
on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared
sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.

INTENDED USE

These orthopedic manual surgical instruments are intended for use in surgical procedures to manipulate tissue, bone, or for use
with other devices in orthopedic surgery. An instrument may incorporate a measuring function which has uses as described on
the label and the instrument.

DO NOT IMPLANT THE INSTRUMENTS.

The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize,
transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic
Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction
with a legally marketed, validated, FDA-cleared sterilization wrap.

Medtronic does not and cannot warrant the use of these instruments or Medtronic Transportation/Sterilization Cassettes 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 or Medtronic Transportation/Sterilization Cassettes, such as on

sharp edges, may cause injury to the patient, or surgical or processing personnel.

▪ Improper maintenance, handling, or inadequate cleaning procedures can render the instrument or Medtronic

Transportation/Sterilization Cassettes (cases, trays, lids) unsuitable for their intended purpose or may even be dangerous to
the patient or surgical or processing personnel.

▪ There are particular risks involved in the use of instruments used for bending and cutting rods. Use of these types of

instruments can cause injury to the patient by virtue of the extremely high forces required. Do not cut rods in situ. Any
breakage of an instrument or implant in this situation could be extremely hazardous. The physical characteristics required
for many instruments do not permit them to be manufactured from implantable materials, and if any broken fragments of
instruments remain in the body of a patient, the patient could have allergic or infectious consequences.

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

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

▪ Correct handling of Medtronic Transportation/Sterilization Cassettes is extremely important. Do not modify Medtronic

Transportation/Sterilization Cassettes. Do not notch or bend Medtronic Transportation/Sterilization Cassettes. Notches,
scratches, or other damage and/or wear in Medtronic Transportation/Sterilization Cassettes occurring during surgery may
contribute to breakage.

PRECAUTIONS

▪ Excessive force applied by instruments to implants can dislodge devices, particularly hooks.
▪ Exposing instruments or Medtronic Transportation/Sterilization Cassettes to temperatures in excess of 275°F (135°C) may

modify the physical characteristics. If instruments or Medtronic Transportation/Sterilization Cassettes are exposed to
temperature exceeding 275°F (135°C), perform an additional inspection to ensure they function as intended. See the
EXAMINATION section for more information.

▪ Extreme care should be taken to ensure instruments and Medtronic Transportation/Sterilization Cassettes remain in good

working order. During the procedure, the proper functioning of instruments and Medtronic Transportation/Sterilization
Cassettes is extremely important. Instruments or Medtronic Transportation/Sterilization Cassettes should not be bent or
damaged.

▪ Misuse of instruments or Medtronic Transportation/Sterilization Cassettes, resulting in corrosion, “freezing-up”, scratching,

loosening, bending, or fracture of components of an instrument or Medtronic Transportation/Sterilization Cassette may
inhibit or prevent proper function.

▪ Instruments should be carefully placed on trays, cleaned after each use, and stored in a dry environment.
▪ Do not use instruments for any action for which they were 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 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.

▪ 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.

▪ Ensure instruments with a measuring function are not worn and any surface engravings are clearly visible.
▪ Medtronic Transportation/Sterilization Cassettes are subjected to repeated stresses related to routine transportation,

cleaning, and sterilization processes. Medtronic Transportation/Sterilization Cassettes should be carefully inspected before
each use to ensure they are fully functional.

▪ Medtronic Transportation/Sterilization Cassettes are not to exceed a maximum weight and load distribution of 11.4kg/25lbs.
▪ Dissimilar metals should be separated from direct contact during sterilization to resist corrosion. Medtronic Transportation/

Sterilization Cassettes are designed with coated or silicone brackets to prevent contact with the stainless steel instruments
contained within Medtronic Transportation/Sterilization Cassettes.

POSSIBLE ADVERSE EFFECTS

▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints.
▪ Infection if instruments or Medtronic Transportation/Sterilization Cassettes are not properly processed.
▪ 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 surgical or processing personnel.
▪ Bony fracture in cases of deformed spine or weak bone.
▪ Tissue damage to the patient, physical injury to surgical personnel, and/or increased operating time that may result from the

accidental disassembly of multi-component instruments occurring during surgery.

▪ The methods of use of instruments are 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 (US) law restricts these devices to sale by or on the order of a physician.
These devices should only be used by physicians familiar with the devices, their intended use, any additional instrumentation,

and any available surgical techniques. In addition, these devices should only be processed by operators familiar with the
devices and the processing information contained within this document.

PACKAGING

Instruments may be shipped in stand-alone packaging or in Medtronic Transportation/Sterilization Cassettes. Stand-alone
packaging, Medtronic Transportation/Sterilization Cassettes, and the contained medical devices should be intact upon receipt.
Medtronic Transportation/Sterilization Cassettes and contained medical devices should be checked for completeness and

should be checked for signs of damage prior to use. Damaged packages, cassettes, or instruments 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 cracks, bending, deformation, or distortion, and that all components
are complete.

Medtronic Transportation/Sterilization Cassettes must be examined by the user prior to use. Examination should be thorough
and must include a visual and functional inspection. Examination must also ensure the Medtronic Transportation/Sterilization
Cassettes are complete. Do not proceed with processing of damaged Medtronic Transportation/Sterilization Cassettes.

Never use instruments or Medtronic Transportation/Sterilization Cassettes with obvious signs of excessive wear, damage, or
that are incomplete or otherwise non-functional.

Visual Inspection

As applicable, ensure the following:
Instruments:

▪ All laser markings and other markings are legible.
▪ No cracks are present in instrument handles or any part of the instrument.
▪ Discoloration, corrosion, stains, or rust does not exist. If present, follow the instructions in the Limitations on Processing

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 the insulation.
▪ There is no damage to the working ends or tips. The working end should be free of cracks, sharp edged gouges, and other

damage. When applicable, the working end should be sharp.

▪ There is no damage to 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.

Medtronic Transportation/Sterilization Cassettes (cases, trays, lids):

▪ All laser markings and other markings are legible.
▪ No cracks, deformation, or distortion are present.
▪ No discoloration, corrosion, stains, or rust are present.
▪ No cuts or gouges in silicone brackets are present.
▪ No cracks or peeling of nylon coating on metal brackets.
▪ Latches, caddies, modules, or lids, fit/function correctly.

Functional Inspection

As applicable, ensure the following:
Instruments:

▪ 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.

Medtronic Transportation/Sterilization Cassettes:

▪ Any moving parts move freely without sticking, binding, or grinding.
▪ There should be no sharp edges on cassettes.
▪ Latches, caddies, modules, and/or lids, fit correctly.

PROCESSING - GENERAL CONSIDERATIONS

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 processing is contingent upon the thoroughness of cleaning.

Cleaning is the initial step and sterilization occurs later in processing and is intended to kill microorganisms to reduce the
likelihood of transmission and possibilities of infection. To ensure acceptable processing, 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. Medtronic Transportation/Sterilization
Cassettes may be safely and effectively processed using manual or a combination of manual and automated washer-disinfector
(enzymatic) 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 instruments and Medtronic Transportation/Sterilization Cassettes 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

Instruments: 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. High alkaline cleaning agents (>11.0 pH) should not be used.

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

Medtronic Transportation/Sterilization Cassettes: use of neutral detergents, enzymatic cleaners (7.0 – 8.0 pH) soft bristled
brushes and soft pipe cleaners are recommended. Do not use alkaline cleaning agents as the alkaline cleaners will cause
significant damage and render Medtronic Transportation/Sterilization Cassettes unusable.

The following cleaning agents, solutions, or tools should
Cassettes:

not be used on instruments or Medtronic Transportation/Sterilization

▪ 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.

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 water is recommended). One or more of the following processes may be used to treat water defined as
critical water: ultra-filtered (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.

Processing Warnings/Cautions

▪ Do not allow soiled instruments or Medtronic Transportation/Sterilization Cassettes 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 or
Medtronic Transportation/Sterilization Cassettes.

▪ 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 processing instructions before reuse.

▪ Soiled or used instruments should not be loaded into Medtronic Transportation/Sterilization Cassettes for cleaning in an

automated washer-disinfector. Instruments must be cleaned separately from Medtronic Transportation/Sterilization
Cassettes.

▪ Medtronic Transportation/Sterilization Cassettes can only be cleaned using enzymatic (neutral) cleaning solutions.
▪ Certain solutions, (i.e. alkaline based and/or containing bleach, glutaraldehyde, or formalin) may significantly damage the

Transportation/Sterilization Cassettes. These solutions must not be used.

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

contaminated instruments or Medtronic Transportation/Sterilization Cassettes. Caution should be exercised when handling
instruments with sharp points or cutting edges.

▪ Appropriate PPE should be worn when handling or working with contaminated or potentially contaminated materials,

devices and equipment. PPE may include gowns, masks, goggles, face shields, gloves, and shoe covers.

▪ Do not place heavy instruments on top of delicate instruments.
▪ Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization

moisture caused by rapid cooling.

Limitations on Processing

▪ Repeated processing has minimal effect on these instruments or Medtronic Transportation/Sterilization Cassettes.