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
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