Johnson & Johnson DePuy Mitek 108804, Manual

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ExpresSew™ II
Flexible Suture Passer
Rx Only
DESCRIPTION
The ExpresSew ll Flexible Suture Passer
(Figure 1), when utilized with the ExpresSew ll
Suture Needle (Figure 2), is an orthopedic manual
surgical instrument designed to pass 2-0 to #2
braided surgical sutures through tissue in either
arthroscopic or open surgery. The Flexible Suture
Passer has a diameter of less than 5mm. The
needle is retractable. The ExpresSew ll Flexible
Suture Passer is to be used exclusively with the
DePuy Mitek Flexible Suture Passer Needle.
FIGURE 1
A. Needle Deployment Lever
B. Jaw Release Button
C. Jaw Lever
FIGURE 2
D. Notch
E. Nub
F. Needle
INDICATION FOR USE
The ExpresSew ll Flexible Suture Passer is
indicated for passing suture through tissue in
orthopedic surgery.
CONTRAINDICATIONS
Device not to be used on bone or similar hard
tissue.
WARNINGS
Whether used arthroscopically or in open surgery,
the ExpresSew ll Flexible Suture Passer must be
used under direct visualization.
PRECAUTIONS
• This device should be used only by physicians
with a thorough understanding of orthopedic
procedures.
• The ExpresSew ll Suture Needle is for
SINGLE USE ONLY. DO NOT RESTERILIZE
OR REUSE the suture needle.
Reuse of the
needle may cause the needle to fatigue and
break, which could cause patient injury.
• Do not use the ExpresSew ll Flexible Suture
Passer through a cannula less than 5mm in
diameter.
PREPARATION FOR USE
Read the Instructions For Use in its entirety prior to
use of the devices.
1. Inspect for damage to product or sterile barrier
in the case of the disposable needle. Do not
use if product is damaged or sterile barrier is
compromised.
2. Inspect the ExpresSew ll Flexible Suture
Passer prior to use to ensure proper
mechanical function.
3. Steam sterilize the Flexible Suture Passer
according to the instructions in the
STERILIZATION section in this Instructions For
Use.
4. To load the ExpresSew ll Suture Needle into
the Flexible Suture Passer, insert the sharp end
of the needle into the rear of the instrument
(near handle) with the flag up. (Figure 2)
5. Engage the needle by aligning the notch in
the needle to the nub on the suture passer.
(Figure 2)
6. With the jaw closed, actuate the needle
deployment lever ONCE to confirm that the
needle deploys and retracts.
DIRECTIONS FOR USE
1. Open the jaw of the ExpresSew ll Flexible
Suture Passer by pressing the Jaw Release