Contraindications - Bard SORBAFIX Gebrauchsanweisung

PRODUCT DESCRIPTION:
The S F ™ Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic
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absorbable fasteners. The fasteners are dyed with D & C Violet No. 2. The S
is available in a 36cm (laparoscopic) length, including a piloting tip. The fasteners are 6.7mm in length and are
manufactured from Poly (D, L)-lactide. The fixation instrument shafts have an outer diameter of 5 mm, and may be
used in open procedures or with 5 mm trocars in laparoscopic procedures.
• 0113082 S F ™ Absorbable Fixation System, Laparoscopic 15 Fasteners
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• 0113080 S F ™ Absorbable Fixation System, Laparoscopic 30 Fasteners
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ACTIONS
The absorption profile 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 first 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 post implantation. Absorption of the fastener is nearly
complete after 360 days.
INDICATIONS
The S F ™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical
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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 verified visually after application.
3. Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply,
including but not limited to:
• Fixation of vascular or neural structures
• Fixation of bone and cartilage
• Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate
fixation once the fastener is resorbed.
WARNINGS
1. The S F ™ Absorbable Fixation System is intended for Single Use Only – DO NOT RESTERILIZE.
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2. If package is damaged or open, do not use product. Check package for damage prior to use.
3. Do not use beyond the expiration date on the package.
4. Do not use if the temperature indicator is black.
5. As with any foreign material the presence of bacterial contamination may enhance bacterial infectivity.
Accepted surgical practice must be followed with respect to drainage and closure of infected or
contaminated wounds.
6. Users should be familiar with surgical procedures and techniques involving synthetic absorbable
materials before employing S
the risk of wound dehiscence may vary with the site of application and the material used.
7. The device may not fixate through prosthetics derived from biologic material such as xenografts and
allografts. Prosthetic should be evaluated for compatibility prior to use.
8. To prevent patient injury from the piloting tip, stay clear of vessels, nerves, bowel and viscera when
entering the surgical site, manipulating tissue and fixating mesh.
After use, the S
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piloting tip, which should be considered a sharp even when the device is not actuated. Handle and
dispose of in accordance with any local and federal laws regarding medical waste and sharps disposal
requirements to prevent sharps injuries.
PRECAUTIONS
1. Please read all instructions before using the
2. Only persons having adequate medical training and familiarity with surgical techniques should perform surgical
procedures. Consult the medical literature relative to technique, complications and hazards prior to any
surgical procedure.
3. The S F ™ Absorbable Fixation System can be used with most 5 mm trocars. Ensure compatibility by
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inserting the device into the trocar prior to introduction into the patient. The S
System should enter and exit the trocar easily without excessive force. The use of too much force could
damage the instrument.
4. Do not use this device where hemostasis cannot be verified visually after application.
5. Counter pressure should be applied on the skin of the abdominal wall. Avoid placing hand/finger
directly over the area where fastener is being deployed to prevent injury.
6. Insertion of fasteners is possible into some collagenous structures such as ligaments and tendons, but is NOT
possible directly into bone or cartilage. This may damage the device.
7. Avoid excessive trigger force as this may damage the device.
8. If the device locks, remove the device from the patient and lightly tap the trigger forward toward the tip to
release.
F ™ Absorbable Fixation System fasteners for wound closure, as
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F ™ Absorbable Fixation System may be a potential biohazard. This device has a
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F ™ Absorbable Fixation System.
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F ™ Absorbable Fixation
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