Product Description; Contraindications - Bard OptiFix Mode D'emploi

PRODUCT DESCRIPTION

The O F ™ Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic
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absorbable fasteners via a straight shaft. The shaft of the O
length. The fasteners are 6.7mm in length, are manufactured from Poly(D, L)-lactide and are dyed with D
& C Violet No. 2. The fi xation instrument shafts have an outer diameter of 5 mm and may be used in open
procedures or with most 5 mm trocars in laparoscopic procedures.
Absorption profi le of Poly(D, L)-lactide: Simple chemical hydrolysis of the hydrolytically unstable backbone is
the prevailing mechanism for the polymer's degradation. This occurs in two phases. In the fi rst phase, water
penetrates the bulk of the device, preferentially attacking the chemical bonds in the amorphous phase and
converting long polymer chains into shorter water-soluble fragments. Because this occurs in the amorphous
phase initially, there is a reduction in molecular weight without a loss in physical properties, since the device
matrix is still held together by the crystalline structure. The reduction in molecular weight is soon followed by a
reduction in physical properties (bulk erosion), as water begins to fragment the device. In the second phase,
enzymatic attack and metabolism of the fragments occurs resulting in a rapid loss of polymer mass. In-vitro
studies indicate that the fastener retains 100% of its original strength at 60 days. Absorption of the fastener
is nearly complete after 360 days.
INDICATIONS
The O F ™ Absorbable Fixation System is indicated for the approximation of soft tissue and fi xation of
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surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

CONTRAINDICATIONS

1. This device is not intended for use except as indicated.
2. Do not use this device where hemostasis cannot be verifi ed visually after application.
3. Contraindications associated with laparoscopic and open surgical procedures relative to mesh fi xation
apply, including but not limited to:
• Fixation of vascular or neural structures
• Fixation of bone and cartilage
• Situations with insuffi cient ingrowth of tissue into the mesh over time, which could result in inadequate
fi xation once the fastener is absorbed.
4. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of
underlying structures such as nerves, vessels, viscera or bone. Use of the O
System in the close vicinity of such underlying structures is contraindicated. For reference, the length of
the fastener below the fastener head is 6.1 mm, the fastener head is another 0.6 mm (total 6.7 mm).
5. This device should not be used in tissues that have a direct anatomic relationship to major vascular struc-
tures. This would include the deployment of fasteners in the diaphragm in the vicinity of the pericardium,
aorta, or inferior vena cava during diaphragmatic hernia repair.
WARNINGS
1. The O F ™ Absorbable Fixation System is intended for Single Use Only – DO NOT RESTERILIZE.
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Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/
or essential material and design characteristics that are critical to the overall performance of the
device and may lead to device failure which may result in injury to the patient.
Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the
device and/or cause patient infection or cross infection, including, but not limited to, the transmis-
sion of infectious diseases from one patient to another. Contamination of the device may lead to
injury, illness or death of the patient or end user.
2. Do not use beyond the expiration date on the package.
3. Prior to use, carefully examine package and product to verify neither is damaged and that all seals
are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the tem-
perature indicator on the foil pouch is black.
4. As with any implant material the presence of bacterial contamination may enhance bacterial infec-
tivity. Accepted surgical practice must be followed with respect to drainage and closure of infected
or contaminated wounds.
5. Users should be familiar with surgical procedures and techniques involving synthetic absorbable
materials before employing O
the risk of wound dehiscence may vary with the site of application and the material used.
6. The device may not fi xate through prosthetics derived from biologic material such as xenografts
and allografts. Prosthetic should be evaluated for compatibility prior to use.
O F
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Absorbable Fixation System
F ™ Absorbable Fixation System fasteners for wound closure, as
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™
IX
F ™ Absorbable Fixation System is 39cm in
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F ™ Absorbable Fixation
IX