Medtronic NAVNS3606010 Instructions for Use
Medtronic Navigated, Nonsterile,
M708348B622E Rev. B
Single-Use Instruments for use with
StealthStation™ and IPC™
POWEREASE™ Systems
2018-03-06
IMPORTANT INFORMATION ON THE MEDTRONIC NAVIGATED NONSTERILE,
SINGLE USE INSTRUMENTS
DESCRIPTION
Medtronic navigated non-sterile, single-use instruments are spine preparation instruments made of high grade stainless steel.
These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate.
Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computerassisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field.
Medtronic navigated non-sterile, single-use instruments are compatible with various Medtronic spinal implant systems. These
instruments are also compatible with Medtronic’s IPC™ POWEREASE™ System when connected to the POWEREASE™
Driver.
These instruments should never be reused under any circumstances.
INTENDED USE
Medtronic navigated non-sterile, single-use instruments are intended to be used during the preparation and placement of
Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or
minimally invasive, procedures. Medtronic navigated non-sterile, single use instruments are specifically designed for use with
the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be
appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified
relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic navigated nonsterile, single-use instruments are also compatible with the IPC™ POWEREASE™ System.
DO NOT IMPLANT THE INSTRUMENTS
If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic. Any available surgical
techniques will be provided at no charge.
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 under any circumstances. Reuse or reprocessing may
compromise the structural integrity of these instruments and create a risk of contamination, which could result in patient
injury, illness, or death.
▪ 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, since it could cause injury to the patient.
▪ During navigation, it is important to frequently confirm navigational accuracy by touching the tip of the instrument on known
anatomical points, including accuracy checkpoints, and comparing the position of the instrument tip in the image with its
physical location.
PRECAUTIONS
▪ Excessive force applied by instruments to implants can dislodge devices, particularly hooks.
▪ 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 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.
▪ Do not use this instrument for any action for which it was not intended.
▪ To avoid injury or navigation inaccuracy, 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 utilization of the system 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.
▪ 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 that incorporate a measuring function. Ensure instruments with a measuring
function 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 or damage 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.
▪ 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 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.
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.
Only sterile instruments should be used in surgery. Always immediately discard all instruments used in surgery.
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 and the presence of any cracks, bending, deformation, or distortion, and that all components are
complete.
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.
▪ 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. 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.
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