PRODUCT DESCRIPTION:
The P
ERMA
F
IX
™ Fixation System is a sterile single use device that delivers either 15 or 30 permanent
(acetal) fasteners. The shaft of the P
ERMA
F
IX
™ Fixation System is 36 cm in length, including a piloting tip.
The fasteners are 6.7 mm in length. The fixation 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. The device
includes a fastener gauge located on the back of the handpiece. The gauge will move right to left as the
fasteners are deployed and indicates approximate level of fasteners remaining in the device.
15
30
• REF 0113119 P
ERMA
F
IX
™ Fixation System, 15 Fasteners
• REF 0113120 P
ERMA
F
IX
™ Fixation System, 30 Fasteners
INDICATIONS
The P
ERMA
F
IX
™ Fixation System is indicated for the approximation of soft tissue and fixation of 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 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
4. This device should not be used in patients with a known allergy or hypersensitivity to acetal
polymers.
5. 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 P
ERMA
F
IX
™ Fixation
System in the close vicinity of such underlying structures is contraindicated. For reference, the length
of the fastener is 6.0 mm, the fastener head is another 0.7 mm (total 6.7 mm).
WARNINGS
1.
The P
ERMA
F
IX
™ Fixation System is intended for Single Use Only – DO NOT RESTERILIZE.
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
transmission 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.
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.
As with any implant the presence of bacterial contamination may enhance bacterial infection.
Accepted surgical practice must be followed with respect to prevention of infection and
drainage and closure of infected or contaminated wounds.
5.
Users should be familiar with surgical procedures and techniques involving permanent
fixation before employing P
ERMA
F
IX
™ Fixation System fasteners for wound closure, as the risk
of wound dehiscence may vary with the site of application and the material used.
6.
The device may not fixate through prosthetics from naturally derived material such as
xenografts and allografts. Prosthetic should be evaluated for compatibility prior to use.
7.
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 P
ERMA
F
IX
™ Fixation System may be a potential biohazard. This device has a
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 P
ERMA
F
IX
™ Fixation System.
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.
en
15 count fastener
gauge
starts at midpoint and
moves towards left as
fasteners deplete.
30 count fastener
gauge
starts on the right and
moves towards left as
fasteners deplete.
PK3795440 BAW-12.indd 2
PK3795440 BAW-12.indd 2
3/11/2011 8:32:55 AM
3/11/2011 8:32:55 AM
