Adverse Reactions - Smith & Nephew HEALICOIL PK Mode D'emploi

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Warnings
Do not use if package is damaged. Do not use if
the product sterilization barrier or its packaging
is compromised.
• Contents are sterile unless package is opened or
damaged. DO NOT RESTERILIZE. For single use only.
Discard any open, unused product. Do not use after
the expiration date.
• It is the surgeon's responsibility to be familiar with
the appropriate surgical techniques prior to use of
this device.
• Read these instructions completely prior to use.
• Product must be stored in the original sealed
pouch.
• Incomplete anchor insertion may result in poor
anchor performance.
• Breakage of the suture anchors can occur if
insertion sites are not prepared with appropriate
instrumentation prior to implantation.
• Do not attempt to implant this device within
cartilage epiphyseal growth plates or non-osseous
tissue.
• Do not resterilize or reuse anchors, sutures, insertion
devices, or disposable awls.
Precautions
U.S. Federal law restricts this device to sale by or on
the order of a physician.
• Hazards associated with reuse of this device include,
but are not limited to, patient infection and/or device
malfunction.
• Prior to use, inspect the device to ensure it is not
damaged. Do not use a damaged device.
• As in all suture anchor or suturing techniques, until
biological attachment of tissue to bone is complete the
fixation should be considered temporary and may not
withstand weight bearing or other unsupported stresses.
The suture anchor and suture are not intended to provide
indefinite biomechanical integrity.
• Use of excessive force during insertion can cause
failure of the suture anchor or insertion device.
Use a two-finger AO technique to insert the anchor.
• Bone quality must be adequate to allow proper
placement of the suture anchor. Inadequate bone
quality could result in loss of fixation or pullout of the
suture anchor.
• Do not alter the implant or instrumentation or
performance may be compromised.
• Do not use sharp instruments to manage or control
the suture. Breakage of the suture can occur if there is
damage caused by sharp instruments.
• After use, this device may be a potential biohazard and
should be handled in accordance with accepted medical
practice and applicable local and national requirements.

Adverse Reactions

• Mild inflammatory reaction
• Foreign body reaction
• Infection, both deep and superficial
• Allergic reaction
Instructions for Use
1. Using routine sterile technique, remove the HEALICOIL™
PK Preloaded Suture Anchor with the attached insertion
device from the package.
2. Use the appropriate Smith & Nephew awl or drill to
prepare the insertion site.
• For general use, disposable and reusable awls are
sold separately.
• When a larger hole is required, as in the case of hard
bone, reusable drills and awl-dilators specific to the
suture anchor are sold separately.
• Refer to the table below for the recommended awl
or drill.
Suture Anchor
HEALICOIL PK
4.5 mm
HEALICOIL PK
5.5 mm
4
10600803 Rev. B
For General Use
REF 72202621,
3.8 mm Tapered awl,
disposable
REF 72201915,
3.8 mm Tapered awl,
reusable
HEALICOIL™ PK Preloaded Suture Anchors
For Hard Bone
REF 72203482,
3.5 mm Spade tip drill
REF 72203335,
4.5 mm Awl-dilator
REF 72203483,
4.5 mm Spade tip drill
REF 72203336,
5.5 mm Awl-dilator
Instructions for Use