M708348B102E Rev A
MEDTRONIC FACET SCREW INSTRUMENTS
ENGLISH
MEDTRONIC FACET SCREW INSTRUMENTS
INTENDED USE
The Medtronic Facet Screw Instruments are intended to aid in the implantation of cannulated
facet screws. These instruments are intended for single level access use only.
2012-08
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132, USA
Telephone 800 933 2635 (In U.S.A.)
901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
INSTRUCTIONS FOR USE
DEVICE DESCRIPTION
11 Gauge Needle (aka Jamshidi needle)
The needle is used for initial access to the facet joint.
Guidewire
The Guidewire’s sharp tip is drilled through the facet joint and into the pedicle, and guides the
cannulated tools to the facet through an over-the-wire placement. The Guidewire has a marker
band used in conjunction with the Access Introducer to measure the screw length needed for
facet joint fixation.
Access Introducer
The Access Introducer consists of a cannula placed over a stylet and attached together by a
threaded handle. The instrument is placed over the Guidewire and seats against the facet joint.
The Access Introducer has depth markers on the stylet handle that are used in conjunction
with the Guidewire to measure the screw length needed. After the reading is taken, the stylet is
removed. The remaining cannula acts as a guide for successive cannulated instruments to be
passed over-the-wire.
pg. 1 of 10
Access Introducer (assembled)
Access Introducer Stylet
Access Introducer Cannula
Cannulated Drill Bit
The Drill Bit provides the pilot hole for the facet screws. The diameter of the Drill Bit is equal to
the minor diameter of the facet screw. The Drill Bit is placed over the Guidewire and into the
cannula; it creates a pilot hole across the facet joint and into the pedicle. The Drill Bit attaches
to a surgical drill provided by the hospital.
Drill Clip
The Drill Clip is used in conjunction with the Cannulated Drill Bit. A single Drill Clip is attached
to the Drill Bit and provides a depth stop to limit drill advancement. The Drill Clip attaches to
one of the four notches commensurate with the chosen screw length.
Screw Driver
The Screw Driver places the screw across the facet joint and into the pedicle. The instrument
is placed over the Guidewire and into the cannula with the screw attached to the distal end.
Once the tip of the screw is in contact with the facet, the instrument is used to drive the screw
across the facet joint and into the pedicle. After the screw is placed, a secondary knob is used
to tighten the nut on the screw. Lastly, the instrument is detached from the screw and is
removed.
pg. 2 of 10
Castles
CONTRAINDICATIONS
Active infectious process or significant risk of infection (immunocompromise)
Signs of local inflammation
Fever or leukocytosis
Morbid obesity
Pregnancy
Mental illness
Grossly distorted anatomy caused by congenital developmental, traumatic, previous surgery,
or severe degenerative conditions limiting anatomical definition to allow safe screw insertion
Any medical or surgical condition which would preclude the potential benefit of spinal implant
surgery, such as the presence of tumors or congenital abnormalities, elevation of
sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC),
or a marked left shift in the WBC differential count
Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a
relative contraindication since this condition may limit the degree of obtainable correction
and/or the amount of mechanical fixation.
Suspected or documented metal allergy or intolerance
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
WARNINGS
Instruments are considered MR Unsafe and should not be brought into an MR environment.
Breakage of the instruments may require intervention or retrieval.
Do not use these instruments for any action for which they were not intended, such as
hammering, prying, or lifting.
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.
DO NOT IMPLANT THE INSTRUMENTS.
PRECAUTIONS
The Medtronic Facet Screw Instruments are single use devices intended to contact body
tissues. Do not reuse, reprocess, or resterilize. Reusing this device carries the risk of
contamination and may cause patient infection or cross-infection, regardless of the cleaning
and resterilization methods. There is also an increased risk of the deterioration of the device
performance due to the reprocessing steps, which may lead to patient injury or death.
pg. 3 of 10
It is important to read and understand the Instructions for Use carefully prior to use.
Use the Medtronic Facet Screw Instruments prior to the Use By date noted on the package.
Do not use if the package is opened or damaged because product integrity, including
sterility, may be compromised.
Physicians using the instruments should be familiar with the physiology and pathology of the
selected anatomy and be trained in the performance of the chosen surgical technique.
The devices should be manipulated only while under fluoroscopic observation with
radiographic equipment that provides high quality images.
Extreme caution should be used around the spinal cord and nerve roots. Damage to the
nerves can cause loss of neurological functions.
Caution: Be careful that the guidewire, if used, is not inserted too deep, becomes bent,
and/or breaks. Ensure that the guidewire does not advance during instrument transfers
and/or drilling.
Maintain Guidewire positioning throughout procedure. Loss of Guidewire placement may
lead to procedural delays.
Handle and dispose of this product in accordance with accepted medical practice and
applicable laws and regulations
Reconditioning, refurbishing, repair, modification, or resterilization of the product to enable
further use is expressly prohibited
ADVERSE EVENTS
Adverse events potentially associated with the use of the instruments include:
Foreign body (allergic) reaction
Nerve injury including puncture of the nerve roots potentially resulting in radiculopathy,
paresis, or paralysis
Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may
cause injury to the patient or operative personnel
Impingement of close vessels, nerves, and organs by slippage or misplacement of the
instrument
Bursitis
Tissue damage caused by improper positioning and placement of instruments
Unintended puncture wounds including vascular puncture and dural tear
Embolism of fat, thrombus, or other materials resulting in symptomatic pulmonary embolism
or other clinical sequalae
Deep or superficial wound infection
Bleeding or hemorrhage
Hematoma
Pain
Infection
Death
Note: Additional surgery may be necessary to correct some of these potential adverse events.
DIRECTIONS FOR USE
Recommended Materials
Small orthopedic power drill with a guidewire attachment and Jacob’s chuck. Refer to the
manufacturer instructions for proper use of power drill.
pg. 4 of 10
Hex Head Cannulated Facet Screw, like the Anchor FS
TM
Facet Fixation System. The
following dimensions of the Medtronic Facet Screw Instruments are important in selecting a
compatible screw:
o Maximum guidewire Outer Diameter 1.45 mm
o Minimum cannula Inner Diameter: 9.0 mm
o Drill bit size: Ø 3.0 mm
o Driver hex size: 3.5 mm
Note: Before each step of the facet screw placement, check fluoroscopic imaging to ensure
appropriate position of the devices.
1. Using fluoroscopy, introduce the 11 Gauge Needle through the skin. Appropriate trajectory
to place a facet screw in a transfacet-pedicular approach is determined by using the 11
Gauge Needle and fluoroscopy based on patient anatomy.
Figure 1: Medtronic 11 Gauge Needle Placement
2. Once the 11 Gauge Needle is properly aligned, remove the stylet from the 11 Gauge
Needle. Insert the sharp tip of the Guidewire through the needle. Using a power drill, drive
the Guidewire across the facet joint and into the pedicle until the tip appears to reach the
posterior aspect of the vertebral body. Once the Guidewire is properly positioned, remove
the 11 Gauge Needle, taking care to ensure the Guidewire remains in position.
Figure 2: Medtronic Guidewire Placement
pg. 5 of 10
Note: Once the Guidewire is appropriately positioned, ensure that it remains in
position throughout all steps of the procedure.
3. a) Once a skin incision is made, insert the Access Introducer over the Guidewire, and
advance the Access Introducer through the tissue until the distal end makes contact with
the Guidewire entry point on the inferior articular process.
b) Note the depth reading on the Access Introducer stylet. The alignment between the
distal end of the black marker on the Guidewire and the numbering on the Access
Introducer stylet handle indicates the depth of the Guidewire relative to the inferior articular
process entry point.
Figure 3: Medtronic Access Cannula Placement & Depth Measurement
Note: Fluoroscopy should be used in conjunction with Guidewire depth measurement to
ensure proper sizing of the facet screw.
c) Rotate the Access Introducer stylet counter clockwise and remove the stylet from the
Access Introducer cannula. Advance the Access Introducer cannula anteriorly until it makes
contact with the inferior articular process.
4. a) Based on the Guidewire depth measurement noted in Step 3b, attach the Drill Clip to the
Cannulated Drill Bit at the corresponding depth marker, and attach the Cannulated Drill Bit
to a power drill.
Figure 4: Medtronic Drill Bit Assembly
b) Insert the Cannulated Drill Bit, attached to the power drill, over the Guidewire and into
the Access Introducer cannula. Drill across the facet joint and into the pedicle until the
pg. 6 of 10
Cannulated Drill Bit has reached the posterior wall of the vertebral body. Confirm
appropriate drill position via fluoroscopy. The Drill Clip can also be used to provide a hard
stop when the Drill Clip contacts the cannula.
Figure 5: Medtronic Drill Placement
c) To remove the Cannulated Drill Bit, reverse the direction of the drill, and guide the
Cannulated Drill Bit out, while maintaining Guidewire placement.
Note: Maintaining the Guidewire in place while pulling the drill out is critical to
maintain the intended trajectory for subsequent tools. It is recommended to detach
the drill from the drill bit during removal.
5. a) Attach a hex head cannulated facet screw to the Screw Driver by pulling back the gray
knurled knob. Firmly insert the tip of the inner shaft of the Screw Driver into the facet screw.
While holding the facet screw, gradually release the Screw Driver knob. Align the castles
on the Screw Driver with the nut, if applicable.
Figure 6: Medtronic Driver and Screw Attachment
b) Insert the Screw Driver with the attached facet screw over the Guidewire and into the
Access Introducer cannula.
pg. 7 of 10
Figure 7: Retaining Clip Removal
c) Advance the facet screw across the facet joint and into the pedicle until the distal end of
the black marker band on the driver is in line with the top surface of the cannula hub. This
alignment indicates the facet screw has been fully inserted.
d) Using fluoroscopy, verify screw placement and that the washer has made contact with
the inferior articular process, if applicable.
Figure 8: Screw Placement
Note: If desired, the guidewire may be removed once you have begun advancing the
facet screw across the joint.
6. Detach the driver from the facet screw by pulling the driver proximally out of the cannula.
Remove the cannula and guidewire, if not previously removed.
For information specific to facet screw implants including, adverse events, precautions,
cautions, and warnings, refer to the Instructions for Use (IFU) specific to the implant.
STERILIZATION
Sterilized with irradiation.
pg. 8 of 10
HOW SUPPLIED
The Medtronic Facet Screw Instruments are supplied sterile in a peel-open package. In the
event of damage to the sterile packaging, do not use and notify the manufacturer.
STORAGE
The device should be stored in the original shipping materials. Proper care should be taken to
ensure that the instruments will not be damaged. Store in a cool dry place.
LIMITATION OF LIABILITY
MEDTRONIC WILL NOT BE RESPONSIBLE FOR ANY DIRECT, INDIRECT, INCIDENTAL,
CONSEQUENTIAL, OR EXEMPLARY DAMAGES RESULTING FROM REUSE OF THE
MEDTRONIC FACET SCREW INSTRUMENTS.
IN NO EVENT SHALL MEDTRONIC BE LIABLE FOR ANY DIRECT, INDIRECT,
INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES ARISING OUT OF OR IN
CONNECTION WITH THE MEDTRONIC FACET SCREW INSTRUMENTS BASED UPON
BREACH OF CONTRACT (INCLUDING BREACH OF WARRANTY).
REQUESTS FOR INFORMATION
For further information, contact Customer Service, Medtronic Sofamor Danek USA, Inc., 1800
Pyramid Place, Memphis, Tennessee 38132, Telephone: 800 933 2635 (in U.S.A.),
901 396 3133 (outside U.S.A.), Fax 901 396 0356.
©2012 Medtronic Sofamor Danek USA, Inc. All rights reserved.
EXPLANATION OF SYMBOLS
Consult Instructions for Use
Do Not Reuse
Batch Code
Manufacturer
Catalogue Number
Use by
Sterilized using irradiation
pg. 9 of 10
Do Not Use If Package Is Damaged
For U.S. audiences only
Caution: Federal law (U.S.A.) restricts this
device to sale by or on the order of a physician
pg. 10 of 10
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