Medtronic NAV0200 Instructions for Use

Medtronic Navigated Manual

M708348B455E Rev. G

Reusable Instruments for Use with
the StealthStation™ System

2021-05-25

IMPORTANT INFORMATION FOR MEDTRONIC NAVIGATED MANUAL REUSABLE
INSTRUMENTS

Note: not all parts may be available in each geography.

DESCRIPTION

Medtronic Navigated Reusable Instruments are spine preparation instruments fabricated from 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 tracker passive stems allows a Medtronic computer-assisted surgery system
such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. An instrument may
incorporate a measuring function which has uses as described on the label and the instrument.

Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
If the device passes the visual and functional inspection as described in the IFU, the instrument can be expected to perform as

intended for the perioperative period.

INTENDED USE

Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants
during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive
procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems.

Navigated surgical 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. An instrument may incorporate a measuring function, which has uses as described on
the label and the instruments.

Do not implant the instruments.

WARNINGS

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

surgical personnel, or processing personnel.

▪ Improper maintenance, handling, or inadequate cleaning procedures can render instruments unsuitable for the intended

purpose and may present a danger to the patient, surgical personnel, or processing personnel.

▪ 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 instruments or implants, as it could cause injury to the patient.

▪ Immediate-Use Steam Sterilization is only intended for individual instruments and should only be considered under urgent

clinical situations and when approved by local policies.

▪ 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.

▪ To avoid potential navigation inaccuracy, exercise caution to prevent the application of force on the tracker that could bias

the navigated instrument.

▪ When using the Navigated Elevate™ Inserter, only the collapsed position of the implant is navigated. Implant expansion is

not tracked.

▪ When using the Navigated T2 Stratosphere™ Inserter, only the collapsed position of the implant is navigated. Implant

expansion is not tracked.

Medtronic does not and cannot warrant the use of the instruments nor any component parts upon which repairs have been
made or attempted except as performed by Medtronic or an authorized Medtronic repair representative.

PRECAUTIONS

▪ Excessive force applied by instruments can dislodge implanted devices.
▪ Extreme care should be taken to ensure instruments remain in good working order. During the procedure, the proper

functioning of instruments is extremely important. Instruments should not be bent or damaged. Misuse of instruments
resulting in corrosion, binding, scratching, loosening, bending, or fracture of components of instruments may inhibit or
prevent proper function.

▪ 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.

▪ 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

successful use of instruments. Proper selection and compliance of the patient greatly affect results. Read and follow all
product information supplied by the manufacturer of devices.

▪ Extra care should be taken when using instruments in pediatric patients since these patients can be more susceptible to

stresses required in use of instruments.

▪ Ensure instruments with a measuring function are not worn and any surface markings are clearly visible.
▪ Personnel should wear all appropriate Personal Protective Equipment (PPE) as recommended by the sterilizer

manufacturer.

▪ When explanting and/or disposing of a device, be sure to avoid exposure to bodily substances such as blood, tissue, etc.,

as contact could lead to infection or disease. Always wear and use proper equipment, taking special care with sharp objects
and needles. Follow your healthcare center’s policy regarding both the disposal of devices and any events of exposure.

POTENTIAL ADVERSE EFFECTS

▪ Nerve damage, paralysis, pain, and/or damage to soft tissue, visceral organs, or joints.
▪ Infection if instruments are not properly cleaned and sterilized.
▪ 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.
▪ Bone fracture.
▪ Tissue damage to the patient, physical injury to surgical personnel, and/or increased operating time that may result from

accidental disassembly of multi-component instruments occurring during surgery.

▪ Methods of use 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 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.
This device should be used only by physicians familiar with the device, its intended use, and available surgical techniques.

PACKAGING

Medtronic Navigated Surgical Instruments are supplied non-sterile. Instruments may be shipped in stand-alone packaging or in
accessories. Stand-alone packaging, accessories, and contained medical devices should be intact upon receipt. Accessories
and contained medical devices should be checked for completeness and signs of damage prior to use. Damaged packages and
accessories should not be used and should be returned to Medtronic.

EXAMINATION

Instruments must always be examined 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 present.

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

Visual Inspection

Ensure the following:

▪ Laser marking, engravings, and other markings are legible.
▪ No cracks, deformation, or distortion are present.
▪ No Discoloration, corrosion, stains, or rust. are present. If present, wipe the device clean in accordance with the instructions

in the PROCESSING-GENERAL CONSIDERATIONS section of Medtronic Reusable Instruments and Accessories for
processing instructions (0380035).

▪ There is no handle/shaft separation, and the handle-to-shaft connection is secure.
▪ No cuts or gouges in the silicone of instrument handles are present.
▪ There is no damage (cuts, tears, etc.) to insulation.
▪ There is no damage to working ends or tips. The working ends 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

Make certain of the following:

▪ Moving parts move freely without sticking, binding, or grinding. If parts do not move freely, only the use of water-soluble,

steam penetrable lubricant is recommended. Lubricant should be applied only after cleaning cycles and prior to sterilization.

▪ Springs return the handle of the instrument to its original position.
▪ Retention tabs hold appropriate mating parts and are not damaged.
▪ The instrument functions 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.
▪ 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.

DIRECTIONS FOR USE

Instructions for Manual Use – NavLock Compatible Instruments

1. Place single-use sterile spheres on each of the four NavLock™ Tracker stems. Push each sphere onto the stem until it

“clicks” into place. Ensure the sphere is firmly seated on the stem.

2. Place the instrument into the Tracker.
a. Insert the proximal end of the instrument shaft until it is fully seated in the NavLock™ Tracker.

b. Verify the instrument is secured in the NavLock™ Tracker by ensuring it cannot be pulled out of the device.

3. Secure the handle to the NavLock™ Tracker assembly. Note: use only the Medtronic Ratcheting Egg Handle (9734410),

Medtronic Straight Handle (9733734), Quarter Inch Quick Connect T-Handle (G900100), or Quick Connect Ratcheting
Handle (G900000).

a. Retract the collar on the handle and snap the proximal end of the instrument shaft into the handle.
b. Verify the handle is secured to the instrument by ensuring it cannot be pulled out of the device.

4. Verify the assembly.

5. In the procedure software, select the appropriate instrument that corresponds to the instrument attached to the NavLock™

Tracker.

6. Refer to the Synergy™ Spine & Trauma Pocket Guide for additional navigation instructions.

Instructions for Manual Use – Navigated Inserter

1. Place single-use sterile spheres on each of the four Inserter Tracker stems. Push each sphere onto the stem until it “clicks”

into place. Make sure the sphere is firmly seated on the stem.

2. In the procedure software, select the appropriate instrument that corresponds to the instrument being used in the

procedure.

3. Verify inserter and attach implant.
a. For the Navigated Elevate™ inserter:

i. Verification

▪ Locate the distal prong of the inserter labeled “VER.”
▪ Place the prong labeled VER into the reference frame divot.
▪ Face the inserter tracker array toward the camera and wait for the system to verify.

ii. Attach the correct size implant.

▪ Insert the inner locking tube into the inserter shaft.
▪ Mount the implant onto the inserter and thread the inner locking tube into the implant until it is secure and fully seated.

b. For the Navigated T2 Stratosphere™ inserters:

i. Verification

▪ Remove the blue T-handle from the inserter.
▪ Locate the distal, static prong of the inserter labeled “VER.”
▪ Place the prong labeled VER into the reference frame divot.
▪ Face the inserter tracker array toward the camera and wait for the system to verify.

ii. Attach the correct size implant.

▪ Hold the inserter with the gold button facing up.
▪ Pull the blue T-handle back.
▪ Pull the locking ring back.
▪ Press the gold button and slide button mechanism back past the unlock laser mark.
▪ To attach implant to inserter, hold the implant so the self-adjusting multi-axial end cap is facing up and fit the prongs at

the distal tip of the inserter above and below the middle purple set screw.

▪ Press the gold button and slide button mechanism forward past the lock laser mark.
▪ Push the locking ring forward.
▪ Push the blue T-handle forward.

4. In the procedure software, select the appropriately-sized implant projection that corresponds to the size attached to the

inserter.

5. Refer to the Synergy™ Spine & Trauma Pocket Guide for additional navigation instructions.

6. Refer to the appropriate systems instructions for use for additional instructions on device placement, expansion, and

removal.

Refer to the PROCESSING-GENERAL CONSIDERATIONS section of Medtronic Reusable Instruments and Accessories for
processing instructions (0380035).

STORAGE AND SHELF LIFE

For non-sterile instruments and accessories, store in dry, clean conditions at ambient room temperature. Nonsterile instruments
and accessories are reusable and do not have a specified shelf life. End of life is determined by excessive wear and damage
from normal use. Refer to the Limitations on Processing section within 0380035 for more information.

For sterilized instruments and accessories, ensure instruments and accessories are dry before storing. Store in clean, dry
conditions at ambient room temperature. Shelf life of sterilized instruments and accessories is dependent upon the legally
marketed sterilization wrap. The health care facility should establish a shelf life for sterilized instrumentation based on the type
of sterilization wrap used and recommendations of the sterilization wrap manufacturer.

INSTRUCTIONS - INSTRUMENTS ONLY

See the section entitled “INSTRUCTIONS - Instruments Only” in IFU 0380035.

STERILIZATION INSTRUCTIONS FOR INSTRUMENTS

See the section entitled “STERILIZATION INSTRUCTIONS for both Instruments and Accessories” in IFU 0380035.

FURTHER INFORMATION

In case of complaint, or for supplementary information, contact Medtronic.
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If

further information is required, contact Medtronic.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.
Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the

competent authority of the Member State in which they are established.

MRI INFORMATION

Medtronic instruments and accessories are not intended to be used in the magnetic resonance (MR) environment. As such,
Medtronic instruments and accessories were not evaluated for safety and compatibility in the MR environment. Therefore, safety
of Medtronic instruments and accessories in the MR environment is unknown.

©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

Authorized representative in the European Community

Importer

This device complies with applicable European Union
regulations and directives.

This device complies with applicable European Union
regulations and directives.

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Batch code

Manufacturer

Catalogue number

For US audiences only

Non-sterile

Consult instructions for use at this website.

Medical device

Single sterile barrier system

Double sterile barrier system

Single sterile barrier system with protective packaging
inside

Single sterile barrier system with protective packaging
outside