Medtronic RBT011003 Instructions for Use

Medtronic Surgical Instruments for

M708348B825E Rev. D

use with Mazor X Stealth™ Edition

2021-08-25

IMPORTANT INFORMATION ON THE MEDTRONIC SURGICAL INSTRUMENTS FOR
USE WITH MAZOR X STEALTH™ EDITION

DESCRIPTION

Medtronic Surgical Instruments are non-sterile or sterile, single or re-usable instruments that may be used during the
preparation and placement of various Medtronic spinal implants during spinal surgery. Medtronic Surgical Instruments are made
of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or
international standards specifications.

Medtronic Surgical Instruments are specifically designed for use in spinal procedures with Mazor X Stealth™ Edition. Medtronic
Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor
X Stealth™ Edition Arm Guide. Some Medtronic Surgical Instruments (e.g. drills, drivers, taps etc.) are also compatible with
Medtronic’s IPC™ Powerease™ System. When connected to the Powerease™ Driver, these Medtronic Surgical Instruments
may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Some Medtronic Surgical Instruments may or may
not be compatible with AO* style quick connect drilling motors. Medtronic surgical drills shall only be used through the Mazor X
Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Placing Medtronic single-use sterile spheres on
each of the NavLock™ Tracker passive stems allow Mazor X Stealth™ Edition to track the Medtronic Surgical Instruments in
the surgical field. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.

INTENDED USE

Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal
surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical
Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions 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 Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided
through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™
Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also
compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a
measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used
with Midas Rex™ attachments and tools.

Do not implant instruments.
Medtronic does not and cannot warrant the use of these instruments 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, 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 the 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

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

▪ 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.

▪ Single-use 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. This device was designed for single patient use only.

PRECAUTIONS

▪ Excessive force applied by instruments to implants can dislodge devices.

▪ Extreme care should be taken to ensure instruments remain in good working order. During the procedure, successful use of

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

▪ Using drills that are in good working order is essential to maintaining trajectory guidance. Re-usable drills should be

disposed of and replaced if a drill is dull, indicated by excessive force required during drilling.

▪ Never expose instruments to temperatures >275°F (135°C) that may modify the physical characteristics. If instruments are

exposed to temperature >275°F (135°C), perform an additional inspection to ensure they function as intended. See the
EXAMINATION section for more information.

▪ Reusable instruments should be carefully placed on trays, cleaned after each use, and stored in a dry environment.
▪ Non-sterile single-use instruments should be carefully placed on trays and discarded after use.
▪ Do not use instruments for any action for which they are not intended.
▪ Regularly review the operational state of all reusable instruments and, if necessary, make use of repair and replacement

services.

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

successful use of the system. 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 other product information supplied by the manufacturer of implants and 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 use of instruments which incorporate a measuring function. Ensure these are not worn and surface

engravings are clearly visible.

▪ Dissimilar metals should be separated from direct contact during sterilization to resist corrosion.

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 instruments.
▪ 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 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 the

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.
This device should be used only by physicians familiar with the device, its intended use, any additional instrumentation, and any

available surgical techniques.

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.
Individual instruments, Medtronic Transportation/Sterilization Cassettes, and contained medical devices should be checked for
completeness and signs of damage prior to use. Damaged packages, cassettes, or instruments should not be used and should
be returned to Medtronic.

Only sterile instruments should be used in surgery. Damaged packages or products should not be used and should be returned
to Medtronic. All products should be treated with care.

Non-Sterile Reusable Devices: remove all packaging material prior to sterilization. Instruments used in surgery must be cleaned
and sterilized by the hospital prior to use. Always immediately clean and re-sterilize all instruments used in surgery. Instruments
should be thoroughly cleaned prior to re-sterilization. This process must be performed before handling, or before returning
product to Medtronic.

Non-Sterile Single-use Devices: remove all packaging material prior to sterilization. Instruments used in surgery must be
cleaned and sterilized by the hospital prior to use. Always immediately discard instruments used in surgery. This product is
intended for single patient use only. Do not reuse, reprocess, or re-sterilize this product. Medtronic assumes no liability for
products which have been re-processed, re-used, or re-sterilized by health care facilities.

Sterile Devices: this device is supplied sterile and is clearly labeled as such on the package label. Sterility can only be assured if
packaging is intact upon receipt. Medtronic assumes no liability for products which have been re-processed, re-used, or re­sterilized by health care facilities.

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.

Never use instruments with signs of 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.
▪ 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.

▪ The instrument tip and/or shaft is not bent.
▪ 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.

Functional Inspection

Make certain of the following:

▪ Parts intended to move do so 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.
▪ 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.
▪ Ratcheting mechanisms are functional. This includes handles, latches, and other mechanisms. 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

Instruments are precision devices, which may incorporate a measuring function and have uses as described on the label.
Instruments which incorporate a depth measuring function have an accuracy level equivalent to ±0.45mm.

Unless labeled for single use, the instruments may be re-used.

Use with AO* Style Quick Connect Drilling Motors or with compatible Manual Handle

Follow manufacturer instructions of general orthopedic drilling motor for connection of AO* style quick connect drill bits.

Use with Midas Rex™ Attachments and Tools

Follow the instructions provided with the Midas Rex™ attachments and tools.

Use with the IPC™ Powerease™ System

See the IPC™ Powerease™ System package insert (M726750B246) for instructions on how to set up and operate the IPC™
Powerease™ System.

Using the Powerease™ Adapter is optional. See the Powerease™ Adapter package insert (9734925) for instructions on using
the adapter with the Powerease™ Driver.

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 NavLock™ Tracker.
A. Insert the proximal end of the instrument shaft until it is fully seated in the NavLock™ Tracker.

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

3. Attach the NavLock™ Tracker and instrument assembly to the Powerease™ Driver (Figure 1).
A. On the Powerease™ Driver, pull back and hold the quick disconnect to unlock the collet.

Note: the quick disconnect must be held in the unlocked position ① when inserting or removing tools.

B. Insert the proximal end of the NavLock™ Tracker assembly into the collet.
C. Align the flat sides of the instrument shaft with the marks on the collet ⑧ and insert into the collet until fully seated

(Figure 2).

D. Release the quick disconnect to place the assembly in the locked position ②.
E. Verify the NavLock™ Tracker assembly is secured in the Powerease™ Driver by ensuring it cannot be pulled out of the

device.

Table 1: Powerease™ Driver

①

Quick Disconnect Unlocked

②

Quick Disconnect Locked

③

Mechanized Working Collar Locking Pins (2)

④

Variable Speed Trigger

4. Verify the assembly.
A. Select the current color NavLock™ Tracker from the instrument list in the procedure software, ensuring the selected

instrument matches the physical instrument.

B. Ensure the instrument has green status (i.e. it is being tracked by the StealthStation™ system) on the screen.
C. Place the instrument straight into the reference frame divot.
D. Face the NavLock™ Tracker array toward the camera.
E. Wait for the system to verify.

5. Change instruments as needed. Re-verification of the assembly is not required.
A. Select the new instrument from the instrument list in the procedure software. Ensure the instrument selected in the

software matches the physical instrument.

B. Retract the collar on the Powerease™ Driver and remove from the instrument.
C. Depress buttons on both sides of the NavLock™ Tracker and remove the instrument from the NavLock™ Tracker.
D. Place the instrument into the NavLock™ Tracker per step 2.
E. Attach the NavLock™ Tracker and instrument assembly to the Powerease™ Driver per step 3.

F. Visually confirm navigational accuracy by touching the tip of the instrument to known anatomical points and comparing

the position of the instrument tip in the image with its physical location.

When using the Powerease™ Driver with navigation, avoid any bending of the instrument by applying direct force only along the
instrument assembly axis (Figure 3).

⑤

Finger Sensor Trigger

⑥

NIM-ECLIPSE Cable Connector

⑦

Mode Select Switch

⑧

Flat Side Indicators

Instructions for Manual Use

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 NavLock™ 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 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. Continue with steps 4 through 5 in the section entitled “Use with the IPC™ Powerease™ System.”

SANITIZATION

Medtronic single-use non-sterile instruments are considered critical devices and must be sterilized prior to initial use.
Sanitization with disinfectant solutions or chemicals is unnecessary and not recommended.

PROCESSING - GENERAL CONSIDERATIONS FOR REUSABLE DEVICES

Refer to PROCESSING - GENERAL CONSIDERATIONS section of Medtronic re-usable Instruments and Accessories
Instructions for Use (0380035).

Cleaning agents which incorporate abrasives such as pumice, aluminum oxide, iron oxide, etc. that physically scratch off dirt,
stains, and/or tarnish via friction as the user rubs the surface shall not be used on the instruments or Medtronic Transportation/
Sterilization Cassettes.

STERLIZATION INSTRUCTIONS

Only sterile products should be placed in the operative field. Unless marked sterile and clearly labeled as such in an unopened
sterile package provided by Medtronic, all non-sterile instruments used in surgery must be sterilized prior to use. Refer to
STERILIZATION INSTRUCTIONS from the PROCESSING – GENERAL CONSIDERATIONS section of Medtronic re-usable
Instruments and Accessories Instructions for Use (0380035) provided with the product.

STORAGE AND SHELF LIFE

Ensure the non-sterile instruments are dry before storing. Store in dry, clean conditions at ambient room temperature. Non­sterile instruments do not have a specified shelf life.

Non-sterile re-usable instruments: non-sterile re-usable instruments do not have a specified shelf life. End of life (shelf life) is
determined by excessive wear and damage from normal use. Refer to STERILIZATION INSTRUCTIONS from the
PROCESSING – GENERAL CONSIDERATIONS section of Medtronic Reusable Instruments and Accessories Instructions for
Use (0380035) for more information.

Single-use non-sterile instruments: non-sterile single-use instruments do not have a specified shelf life.
Shelf life of sterilized instruments depends on 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 the recommendations of the sterile wrap
manufacturer.

MRI INFORMATION

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

FURTHER INFORMATION

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.

*AO is a trademark of AO Technology.

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

Figure 1: Powerease™ Driver

Figure 2: Instrument Seating in Powerease™ Driver

Figure 3: Powerease™ Assembly

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Authorized representative in the European Community/
European Union

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

Batch code

Manufacturer

Date of manufacture

Catalogue number

For US audiences only

This device complies with applicable European Union
regulations and directives.

Medtronic B.V.

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

This device complies with applicable European Union
regulations and directives.

Non-sterile

Do not re-use

Sterilized using irradiation

Use-by date

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

*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.