Medtronic 25000095 Instructions for Use

Medtronic Reusable Instruments for

M708348B450E Rev. E

use with the IPC™ POWEREASE™
System

2021-07-14

IMPORTANT INFORMATION FOR MEDTRONIC REUSABLE INSTRUMENTS FOR USE
WITH THE IPC™ POWEREASE™ SYSTEM

DESCRIPTION

Medtronic Reusable Instruments compatible with Medtronic’s IPC™ POWEREASE™ System are spine preparation
instruments, manufactured from materials commonly used in orthopedic procedures which meet available national or
international standards specifications. Instruments may be connected to the POWEREASE™ Driver or used manually. These
instruments are also compatible with various Medtronic spinal implant systems.

INDICATIONS FOR USE

The IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and
biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical
procedures.

The IPC™ POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during
spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and
rods.

Do not implant instruments.
If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic.
Medtronic does not and cannot warrant the use of this instrument, nor any instrument component parts upon which repairs were

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 patients or

operative personnel.

▪ Improper maintenance, handling, or poor cleaning procedures can render instruments unsuitable for its intended purpose or

even dangerous to patients or surgical staff.

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

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

PRECAUTIONS

▪ Excessive force applied by instruments to implants can dislodge devices.
▪ Never expose instruments to temperatures >135°C that may considerably modify physical characteristics.
▪ Extreme care should be taken to ensure instruments remain in good working order. During the procedure, successful use of

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

▪ Instruments should be carefully placed in trays, cleaned after each use, and stored in a dry environment.
▪ Do not use instruments for actions for which they are not intended.
▪ Regularly review the operational state of instruments and, if necessary, make use of repair and replacement services.
▪ To avoid injury, instruments should be carefully examined for functionality or damage before use. Damaged instruments

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

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

successful use. Further, proper selection and compliance of patients greatly affect results.

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

and follow all product information supplied by the manufacturer of implants or 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 stresses involved in their use.

▪ Some surgeries require use of instruments which incorporate a measuring function. Ensure these are not worn and 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 instruments.
▪ 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 instruments.
▪ 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 patients, physical injury to operating staff, and/or increased operating time that may result from

disassembly of multi-component instruments occurring during surgery.

▪ 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 results.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information 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 instruments should be used only by physicians familiar with the device, their intended use, any additional

instrumentation, and any available surgical techniques.

PACKAGING

Packages for instrument components should be intact upon receipt. All sets should be checked for completeness and all
instrument components should be checked for signs of damage before use. Damaged packages or products should not be used
and should be returned to Medtronic.

Instruments used in surgery must be cleaned and sterilized by the hospital before use.
Remove packaging material prior to cleaning and sterilization. Only sterile instruments should be used in surgery. Always

immediately clean and resterilize instruments used in surgery. Instruments should be thoroughly cleaned before resterilization.
This process must be performed before handling, or before returning product to Medtronic.

EXAMINATION

Instruments must always be examined by the user before surgery.
Examination should be thorough and must include a visual and functional inspection of working surfaces, spring or torsional

operation, cleanliness of location holes or cannulations, and the presence of cracks, bending, deformation, or distortion, and
that all components 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, corrosion, stains, or rust do not exist. If present, attempt to remove in accordance with the cleaning

instructions provided in the Processing section of this document.

▪ 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 working ends of instruments. Instruments should be free of cracks, sharp edged gouges, and other

damage. When applicable, working ends should be sharp.

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

▪ Parts intended to move will do so freely without sticking, binding, or grinding.
▪ Retention mechanisms hold appropriate mating parts and are not damaged.
▪ Instruments function as intended with the appropriate mating parts.
▪ Ball detents 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.
▪ Driver tips are not worn beyond functional use. If necessary, mate the instrument with the appropriate part.