An applier is supplied sterile. Appliers are for single
patient use and can not be re-sterilized. The appliers are
packaged in a plastic tray with a cover lid.
The depth probe is a reusable non-sterile device. This
probe must be cleaned and sterilized prior to each use.
MATERIALS
Fasteners: Polydioxanone or Polypropylene
Needles: Stainless Steel
Collar: Polycarbonate
Applier: Polycarbonate and Stainless Steel
Probe: Stainless Steel
INDICATIONS
DePuy Mitek Meniscal Fasteners are intended for the
repair of torn meniscal tissue as well as the repair of a
separation of the meniscus from the synovium.
CONTRAINDICATIONS
GENERAL
1. Surgical procedures other than those listed in the
INDICATIONS section.
2. Pathological conditions in the tissue which would
impair secure fixation by sutures.
3. Physical conditions which would eliminate, or tend to
eliminate, adequate tissue strength, or retard tissue
healing: i.e. blood supply limitation, infection, etc.
4. Conditions which tend to preempt patients ability to
heal or the healing period.
Absorbable Fasteners Only
These fasteners should not be used where prolonged
(beyond six weeks) approximation of tissue under stress
is required.
INSTRUCTIONS FOR USE
SET-UP
1. Measure distance across meniscus, with probe, to
determine length of fastener to be used. (Fig. 1)
2. Open fastener package using routine
aseptic technique.
3. Pull up on the "Needle Lock Lever" on the Applier to
expose the chuck. (Fig. 2) Insert applier shaft into
open end of needle package and into the connector
end of the needle until the needle clicks onto the
applier. (Fig. 3)
4. Push down the "Needle Lock Lever" to advance the
sleeve over the needle and secure it in place. (Fig. 4)
4