POWEREASE™ System Working Ends M708348B070E Rev. D
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IMPORTANT INFORMATION ON THE POWEREASE™ SYSTEM WORKING ENDS
2013-01-23
AUSTRALIAN SPONSOR:
North Ryde, NSW 2113 Memphis, TN 38132 6422 PJ Heerlen
Australia Telephone 800 933 2635 (In U.S.A.) The Netherlands
901 396 3133 (Outside U.S.A.) Tel: + 31 45 566 80 00
Fax 901 396 0356
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Medtronic Australasia Pty Ltd Medtronic Sofamor Danek USA, Inc. Medtronic B.V.
97 Waterloo Rd 1800 Pyramid Place Earl Bakkenstraat 10
ENGLISH
IMPORTANT INFORMATION ON THE POWEREASE™ SYSTEM WORKING ENDS
PURPOSE
The instruments are working ends that are intended to be used in surgical procedures in the thoracic, lumbar, and sacral spine.
DESCRIPTION
The working ends are compatible with the IPC POWEREASE™ System and the NIM-ECLIPSE® System. The working ends consist of instruments such as taps, drill bits, reduction nut drivers, screw
drivers, rod cutter, post cutter, set screw break-off tool, and sleeves. The working ends have a manual alternative.
The working ends are compatible with the CD HORIZON® SOLERA™ Spinal System and the TSRH® 3Dx Spinal System.
The taps, screw drivers, drill bits, and sleeves are also compatible with Medtronic’s NIM-ECLIPSE® Spinal System.
INDICATIONS
The working ends are intended for drilling, tapping, or driving screws during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE™ System is also used in
the placement or cutting of screws, posts, and rods.
DO NOT IMPLANT THE INSTRUMENTS.
If there is any doubt or uncertainty concerning the proper use of this instrument, please 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.
See the MDT Catalog or price list for further information about warranties and limitations of liability.
DIRECTIONS FOR USE
The instruments are precision devices which may incorporate a measuring function and have uses as described on the label.
Unless labeled for single use, the instruments may be re-used.
See the IPC POWEREASE™ System package insert for instructions to assemble the working ends to the POWEREASE™ driver.
Taps, Drill Bits and Drivers
Once a tap, reduction nut driver, or drill bit is attached to the POWEREASE™ Driver, the instrument is ready to use.
1. To attach an MAS, FAS, or RMAS screw to the screwdriver working end, align the driving tip within the screw and tighten the screwdriver’s sleeve into the screw.
2. To attach a Posted Screw to the Post Screwdriver, first assemble the screwdriver base components by threading them together.
a. Insert the screw into the tip so that the screwdriver captures the screw rotationally.
3. To attach a Threaded Post Screw to the Threaded Post Screwdriver, insert the screw into the tip so that the screwdriver captures the screw rotationally.
4. To attach an MPA screw to the Locking MPA™ Screwdriver, first assemble the screwdriver base components by sliding the Locking MPA™ Driver Shaft into the Locking MPA™ Sleeve and
threading them together.
a. Insert the screw into the tip so that the screw is fully seated
b. Rotate the cap clockwise on the Locking MPA™ Sleeve until the Locking MPA™ Screwdriver securely holds the MPA™ Screw.
c. To lock the cap, pull down and rotate the cage on the Locking MPA™ Sleeve, then release so that the teeth between the cage and the cap engage.
Instructions for Manual Use
1. Insert working end into the ratcheting handle provided in the implant set by aligning the working end with the ratcheting handle.
2. Insert until fully seated within the handle.
Note
• Only use ratcheting handles compatible with the specific working end.
• Drill bits are single use only.
• Taps and drill bits are marked in 1cm increments. The depth indication is measured from the tip of the working end to the horizontal band.
Optional
A sleeve is provided which can be used as a secondary handle for stability while tapping the bone or driving a screw with the POWEREASE™ Driver.
1. Determine the proper size sleeve to use with the tap, drill bit, or screwdriver.
2. Slide the sleeve onto the working end so that the wide part of the sleeve is at the back of the working end. The sleeve will hit a physical stop. For taps 8mm and larger and MPA™ Screwdriver,
the 8.0mm sleeve must slide over the back of the working end prior to attachment to the POWEREASE™ Driver.
3. Rotate the colored Cam on the sleeve in the direction of the arrow.
Setscrew Break Off (SSBO) Instrument
1. Select the appropriate Counter Torque.
2. Attach the Counter Torque to the SSBO instrument by sliding the Counter Torque over the SSBO Breaker Shaft.
3. Press the lock button and hold it.
4. Slide the Counter Torque into the Body of the SSBO Instrument.
5. Release the Lock Button.
6. Attach the SSBO Instrument to the POWEREASE™ Driver.
7. Align the SSBO Instrument Breaker Shaft with the set screw and press down to seat the Breaker Shaft fully over the set screw.
8. Once the SSBO Instrument Breaker Shaft is fully seated onto the set screw, press the SSBO instrument down and rotate the SSBO Instrument until the Counter Torque cut-outs are aligned
with the rod.
9. Once the Counter Torque is aligned with the rod, fully seat the Counter Torque over the rod by pressing down on the SSBO Instrument.
10. Once the Counter Torque is fully seated, run the POWEREASE™ Driver in forward mode until the set screw is broken. The broken set screw heads are stored in the Breaker Shaft.
11. Pull the SSBO instrument away from the construct.
Instructions for Purging Stored Set Screw Heads from the Breaker Shaft
The Breaker Shaft of the SSBO Instrument can hold between 10 and 14 broken set screw heads depending on the spinal system used. When the Breaker Shaft becomes full of broken set screws,
or at the completion of surgery, it is necessary to purge the broken set screw heads.
1. Remove the Counter Torque from the SSBO Instrument.
2. Insert an Obturator into the front of the Breaker Shaft of the SSBO Instrument.
3. Press inward until all the broken set screw heads are ejected from the side port of the Breaker Shaft.
Note
• Light rotation of the SSBO Instrument may be necessary to seat onto the set screw.
• If the Counter Torque resists being fully seated, briefly press the POWEREASE™ Driver trigger.
• The SSBO Instrument’s drive train is not connected to the Breaker Shaft until the Counter Torque is fully seated onto the rod.
Instructions for Manual Use
1. Follow all the steps described for attaching the SSBO Instrument to the POWEREASE™ Driver, with the exception of Step 2.
2. For Step 2, instead of the POWEREASE™ Driver, a manual handle with the Square Adapter attached may be used to drive the SSBO Instrument.
Post Cutter
The Post cutter is used to cut long post screws that are made from Titanium Alloy and have a diameter of 5.2mm. If using a break-off set screw, the set screw head must be removed prior to
using the Post Cutter.
1. Attach the Post Cutter to the POWEREASE™ Driver.
2. Ensure that the Post Cutter is in the open position by running the Post Cutter in reverse until the Post Cutter mechanism is no longer changing, as indicated by the horizontal lines at the
pivot point on the Post Cutter arms.
3. Position the Post Cutter over the post so the Post Cutter is flush with the connector.
4. Run the Post Cutter in forward until the post is cut.
To Remove the Cut Portion of the Post:
5. Move the Post Cutter away from the patient.
6. Run the Post Cutter in reverse. The cut post will be able to slide out the back of the Post Cutter.
Instructions for Manual Use
In step 1 of the previous section, attach the Post Cutter to a manual handle with the Square Adapter instead of the POWEREASE™ Driver. Follow the remaining steps for using the Post Cutter.
Rod Cutter
The Rod Cutter is used to cut surgical rods of material types such as Titanium Alloy, Titanium CP, CHROMALOY™, and CHROMALOY™ Plus in diameters ranging from 4.75mm to 6.0mm.
1. Attach the Rod Cutter to the POWEREASE™ Driver.
2. Ensure that the Rod Cutter is in the open position by running the Rod Cutter in reverse until the Rod Cutter mechanism is no longer changing, as indicated by the horizontal through holes
being aligned.
3. Ensure that both ends of the rod are tightly held to reduce the risk caused by projectile rod pieces.
NOTE: Do not cut rods in-situ.
4. There are two methods of cutting a rod: Scissor Cutting and Shear Cutting.
a. For Scissor Cutting, place the rod between the cutting tips so that the rod is touching both surfaces.
b. For Shear Cutting, pass the rod through the hole that correlates to its size (5.5mm rod through a 6.0mm hole). The cutting point is 6mm beyond the entry holes.
5. Run the Rod Cutter in forward until the rod is cut. It may be necessary to run the Rod Cutter in reverse to remove the cut portion of the rod.
Instructions for Manual Use
Follow all the steps described in the previous section for using the Rod Cutter with the POWEREASE™ Driver, with the exception of step 1. In the place of the POWEREASE™ Driver, a manual
handle with the Square Adapter attached may be used to drive the Rod Cutter.
Note for Post Cutter and Rod Cutter
The Post Cutter and the Rod Cutter should be lubricated between every surgical use to ensure smooth performance and a long service life. Lubricate hinges, threads, and other moving parts
with a commercial water-based surgical grade instrument lubricant (such as instrument milk) to reduce friction and wear. Follow lubricant manufacturer’s instructions.
WARNINGS
• 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.
• There are particular risks involved in the use of instruments used for bending and cutting rods. The use of these types of instruments can cause injury to the patient by virtue of the extremely
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high forces which are involved. DO NOT CUT RODS IN SITU. In addition, any breakage of an instrument or the implant in this situation could be extremely hazardous.
• It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels and that the forces applied while correcting the position of
the instrumentation is not excessive, such that it might cause injury to the patient
PRECAUTIONS
• Excessive force applied by instruments to implants can dislodge devices, particularly hooks.
• Never expose instruments to temperatures in excess of 135 °C that may considerably modify the physical characteristics.
• Extreme care should be taken to ensure that this instrument remains 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.
• These instruments should be carefully placed on trays, cleaned after each use, and stored in a dry environment.
• Do not use this instrument for any action for which it was not intended.
• Regularly review the operational state of all instruments and, if necessary, make use of repair and replacement services.
• 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 utilization of the system by the surgeon. Further, 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 which incorporate a measuring function. Ensure that these are not worn and any 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 the instrument.
• 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 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 to be 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.
Instruments supplied sterile are designed for single patient use only. Do not reuse, reprocess, or resterilize these products. Reuse, reprocessing, or resterilization may compromise the structural
integrity of the instrument and/or create a risk of contamination of the instrument, which could result in patient injury, illness, or death.
FOR US AUDIENCES ONLY
CAUTION: FEDERAL (U.S.) LAW RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN ONLY.
This device should be used only by physicians familiar with the device, its intended use, any additional instrumentation, and any available surgical techniques.
PACKAGING
Packages for components should be intact upon receipt. All sets should be checked for completeness and all components should be checked for signs of damage prior to use. Damaged packages
or products should not be used and should be returned to Medtronic.
Remove all packaging material prior to sterilization. Only sterile instruments should be used in surgery. 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.
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, cleanliness of location holes or
cannulations, and the presence of any 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 Reprocessing 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 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.
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• 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:
• The parts intended to move will 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.
• 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.
REPROCESSING
Refer to the Reprocessing Instructions for the POWEREASE™ System Working Ends package insert (M708348B184) for the cleaning instructions and sterilization parameters and requirements.
FURTHER INFORMATION
In case of complaint, or for supplementary information, contact Medtronic.
MRI INFORMATION
These instruments should not be introduced into the MR environment.
PRODUCT COMPLAINTS
Any health care professional (e.g., user of this system of products) having any complaints or having experienced any dissatisfaction in the product quality, identity, durability, reliability,
safety, effectiveness, or performance should notify the distributor or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions” (i.e., does not meet any of its
performance specifications or otherwise does not perform as intended), or is suspected of doing so, the distributor should be notified immediately. If any Medtronic product ever “malfunctions”
and may have caused or contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written correspondence. When filing a
complaint, please provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint, and notification of whether or not a written report from
the distributor is requested.
©2013 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Caution: Federal law (U.S.A.) restricts this device to sale by
or on the order of a physician
Consult instructions for use
Do not re-use
Use-by date
Batch code
Catalogue number
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EXPLANATION OF SYMBOLS
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Non-sterile
Caution: For U.S. audiences only.
Manufacturer
The device complies with European Directive MDD 93/42/EEC
The device complies with European Directive MDD 93/42/EEC
Authorized representative in the European Community
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