Johnson & Johnson DePuy Mitek SPIRALOK User manual

SPIRALOK™
Absorbable Threaded
Suture Anchor
DePuy Mitek, Inc.
325 Paramount Drive
Raynham, MA 02767, USA
1-800-356-4835
DePuy International Ltd.
St Anthony’s Road, Beeston
Leeds LS11 8DT
United Kingdom
Tel: [phone]
Fax: [phone]
P/N: 108362 Rev: D 07/07

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ENGLISH
SPIRALOK™ Absorbable Threaded
Suture Anchor
Rx Only
DESCRIPTION
The SPIRALOK anchor is a Poly Lactic Acid (PLA)
threaded suture anchor preloaded on a disposable
inserter assembly intended for fixation of two strands
of #2 suture to bone. The ETHIBOND®Non-Absorbable
Braided Suture, PANACRYL®Absorbable Braided Suture
and ORTHOCORD™ Braided Composite Suture options
include tapered needles to facilitate suture passage
through tissue. The SPIRALOK anchor is also packaged
without needles for arthroscopic use.
MATERIALS
Handle: ABS
Shaft: Stainless steel
Anchor: PLA absorption is expected to be essentially
complete in four years, D&C blue dye #6.
Suture: See package label for type and number
of strands:
1. PANACRYL‚ Poly (L-Lactide/Glycolide), braided
absorbable suture. PANACRYL sutures meet or
exceed the USP tensile strength requirements
for nonabsorbable and absorbable suture.The
results of implantation studies of PANACRYL
braided absorbable suture in animals indicate
that approximately 80% of its original strength
remains 3 months after implantation. At 6 months
post-implantation, approximately 60% of its original
strength is retained. *
OR
2. ETHIBOND‚ braided polyester, non-
absorbable suture.
OR
3. ORTHOCORD Suture is a synthetic, sterile, braided,
composite suture composed of dyed (D&C Violet #2
or D&C Blue #6) absorbable polydiaxanone (PDS)
and un-dyed non-absorbable polyethylene. The
partially absorbable suture is coated with a copolymer
of 90% caprolactone and 10% glycolide.
The PDS copolymer has been shown to be nonantigenic,
nonpyrogenic and elicits only a slight tissue reaction
during absorption.

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Needles: Stainless steel. See package label for type
and size.
INDICATIONS
Shoulder: Rotator cuff repair.
CONTRAINDICATIONS
Surgical procedures other than those listed in the
INDICATIONS section; pathological conditions of bone,
such as cystic changes or severe osteopenia, which
would compromise secure anchor fixation; pathological
conditions in the soft tissue to be attached which
would impair secure fixation by suture; comminuted
bone surface, which would compromise secure anchor
fixation; physical conditions which would eliminate, or
tend to eliminate, adequate implant support or retard
healing, i.e., blood supply limitation, infection; conditions
which tend to preempt the patient’s ability to heal or
the healing period, such as senility, mental illness, or
alcoholism; attachment of artificial ligaments or other
implants; reattachment of intracapsular knee ligaments
(ACL & PCL).
INSTRUCTIONS FOR USE
For use arthroscopically, insert the SPIRALOK Delivery
guide and Introducer through the appropriate sized
cannula and place against the bone at the desired
insertion site. Remove the introducer and follow the steps
below. The instruments and the SPIRALOK anchor will fit
through the SPIRALOK delivery guide.
5.0mm SPIRALOK
1. Minimum space between each anchor is 5mm.
2. Position the awl on the prepared bone surface and
establish the proper axial alignment.
3. Using a mallet, tap the awl into the bone until the
etched depth marking is flush with the bone surface.
4. Grasp the handle of the awl firmly and remove it
from the bone by pulling at the same axial angle of
insertion. Set the awl aside for next anchor insertion.
5. In harder bone, the awl may be used first followed by
the tap.
5A. Position the SPIRALOK TAP into the hole
in the bone made by the awl and establish
axial alignment.
5B. Rotate the tap in a clockwise direction until the
etched depth marking is flush with the bone. The
tap may be rotated up to one additional turn (3-4
mm) past the etched depth marking.
5C. Rotate the tap in a counter-clockwise direction
to remove.
6. Insert the SPIRALOK anchor into the hole created by
the awl while maintaining same axial alignment.
7. Rotate the SPIRALOK inserter handle in a clockwise
direction until the etched depth marking on the handle

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is flush with the bone. The four longitudinal lines at
the distal end of the inserter indicate the position of
the suture limbs as they are positioned through the
anchor’s dual suture eyelets.
8. Release the suture card from the inserter handle and
pull inserter away from anchor.
9. Apply tension (nominal force) on suture lengths.
EXCESSIVE TENSION MAY OVERLOAD THE
ANCHOR OR SUTURE.
10. Use the two sutures provided for soft tissue fixation.
6.5mm SPIRALOK
1. Minimum space between each anchor is 5mm.
2. Position the awl on the prepared bone surface and
establish the proper axial alignment.
3. Using a mallet, tap the awl into the bone until the
etched depth marking is flush with the bone surface.
4. Grasp the handle of the awl firmly and remove it
from the bone by pulling at the same axial angle of
insertion. Set the awl aside for next anchor insertion.
5. Position the SPIRALOK TAP into the hole in the bone
made by the awl and establish axial alignment.
6. Rotate the tap in a clockwise direction until the etched
depth marking is flush with the bone. The tap may be
rotated up to one additional turn (3-4 mm) past the
etched depth marking.
7. Rotate the tap in a counter-clockwise direction
to remove.
8. Insert the SPIRALOK anchor into the hole created
by the awl and tap while maintaining same
axial alignment.
9. Rotate the SPIRALOK inserter handle in a clockwise
direction until the etched depth marking on the handle
is flush with the bone. The four longitudinal lines at
the distal end of the inserter indicate the position of
the suture limbs as they are positioned through the
anchor’s dual suture eyelets.
10. Release the suture card from the inserter handle and
pull inserter away from anchor.
11. Apply tension (nominal force) on suture lengths.
EXCESSIVE TENSION MAY OVERLOAD THE
ANCHOR OR SUTURE.
12. Use the two sutures provided for soft tissue fixation.
WARNINGS
1. DePuy Mitek anchors are designed to lock into
cortical or cancellous bone. Bone stock must
be adequate to allow proper and secure anchor
placement. Incomplete insertion or poor bone quality
may result in anchor pullout.
2. Anchor may break or fracture if the bone quality is too
hard or dense.
3. Immediate range of motion should be avoided to
allow biological bony/soft tissue healing.

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4. Do not use where pre-healing suture tension will
exceed 20 lbs. for size #2 suture, as suture may fail.
5. This device is not approved for screw attachment or
fixation to the posterior elements (pedicles) of the
thoracic or lumbar spine.
6. As a braided suture, which is essentially absorbed
over 1.5 to 2.5 years, the PANACRYL suture may act
as a foreign body over an extended period of time.
The surgeon should consider whether use of an
absorbable suture is appropriate in specific situations
such as in wounds that carry an increased risk of
infection or contamination.
7. Users should be familiar with surgical procedures and
techniques involving absorbable and non-absorbable
suture before employing ORTHOCORD suture for
wound closure, as risk of wound dehiscence may
vary with the site of application and the suture
material used.
PRECAUTIONS
A surgeon should not begin clinical use of a DePuy Mitek
anchor without reviewing the instructions for use and
practicing the procedure in a skills laboratory.
Inspect all instruments for damage before use. Do not
attempt to repair.
ADVERSE EFFECTS
Adverse effects of absorbable implanted devices include
mild inflammatory and foreign body reactions.
STERILIZATION
The SPIRALOK suture anchor is provided sterile. Do
not resterilize.
A DEPUY MITEK ANCHOR MUST NEVER BE
REUSED.
STORAGE
Store in a cool dry place below 26°C (80°F), away from
moisture and direct heat. Discard if open but unused. Do
not use after expiration date.
*Data on File
ESPAÑOL
Anclaje de sutura roscado absorbible
SPIRALOK™
DESCRIPCIÓN
El anclaje SPIRALOK es un anclaje de sutura roscado
de ácido poliláctico (APL) previamente cargado sobre
un conjunto insertador desechable para la fijación
de dos hilos de sutura calibre 2 al hueso. La sutura
trenzada no absorbible ETHIBOND®, la sutura trenzada