Neoligaments Fastlok 102-1380 Instrucciones De Uso página 4

English
Implants
102-1380 6 mm x 23 mm Fastlok
102-1381 8 mm x 23 mm Fastlok
Instruments (supplied separately)
202-1137 Impactor Assembly
202-1118 Sliding Hammer
General Use
The Fastlok consists of a staple and buckle and is
intended for the attachment of sutures or tapes to
bone, for soft tissue and connective tissue repairs,
tendon transfers, or autogenous and/or prosthetic
ligament reconstruction, repair or replacement. Use
the Neoligaments Impactor Assembly with the Fastlok,
and vice versa, and follow the instructions given in
this leaflet. Fastloks are suitable for USP 2 (Metric 5)
sutures or larger.
Important
The Impactor Assembly 202-1137 can only be used
with Fastlok products 102-1380, or 102-1381 and vice
versa.
Sterility
The Fastlok is provided sterile, and remains so unless
the package is damaged or opened.
Indications
Various soft tissue and connective tissue repairs
including:
1. Tendon repairs, transplants or transfers in which
the tendon is connected to bone via sutures or
tapes.
2. Ligament repairs, reconstruction or replacement in
which the ligament material is connected to bone
via sutures or tapes.
3. Prosthetic ligament reconstructions and the
attachment of other synthetic materials to bone.
Contraindications
1. Any structural or pathologic condition of the bone
or of the soft tissue being fixed which can be
expected to impair secure fixation by the device.
2. Other physical conditions that would eliminate
or tend to eliminate adequate implant support or
retard healing (blood supply limitation, infections,
etc.).
3. The patient's inability or lack of willingness to
restrict activities to prescribed levels or follow
the rehabilitation programme during the healing
period.
4. If the patient is suspected of having any foreign
body sensitivity, appropriate tests should be made
prior to material selection or implantation.
Warnings and Precautions
1. The general principles of patient selection and
sound surgical judgement apply to the fixation
procedure.
2. Use the device only for the listed Indications
in patients whose conditions are not listed as
Contraindications above.
3. The appropriate size implant should be
preselected by the surgeon based on the bulk of
the material to be attached.
4. Use care in storage and handling of implant
components, and examine components for
damage or defects prior to implanting. Care
should be taken not to damage either the
ligament, staple or buckle during surgery.
5. Postoperative activities should be controlled to
ensure patient compliance with the prescribed
rehabilitation programme.
6. The patient should be informed of the possibility
that the Fastlok may need to be removed if the
patient experiences persistent problems related to
the device.
7. Removal of the Fastlok is optional but should
normally be delayed for a minimum of one year to
allow proper healing.
8. A removed Fastlok must never be reused and
should either be discarded or returned to the
manufacturer, within formalin, if an evaluation is
required.
9. Take care not to over-impact the Fastlok to avoid
damaging the sutures or tapes.
Potential Adverse Effects
1. Loosening, bending, or fracture of the staple and/
or buckle plate may result in loosening of the
material fixation to the bone.
2. Infections, both deep and superficial.
3. Patient foreign body sensitivity and adverse
reaction to device materials.
4. Pain and inflammation at device location.
Packaging and Labelling
1. The Fastlok implants should be accepted only if
the factory packaging and labelling arrive intact.
2. Contact the Neoligaments Sales Department if
package has been opened or altered.
Storage
Products must be stored in the original unopened
packaging away from moisture, dust, insects, vermin,
and extremes of temperature and humidity.
Material Specifications
The Fastlok is made from titanium alloy Ti-6Al-4V
(ISO 5832-3 or ASTM F136).