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OptiFix™ OptiFix™ Absorbable Fixation System

OptiFix™ Absorbable Fixation System - 15 Absorbable Fasteners

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Overview

The OptiFix™ Absorbable Fixation System has been engineered inside and out to provide surgeon confidence and secure fixation in a reliable, easy to use, and ergonomic design.

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Features and Benefits
Promotional Story
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References

1. Preclinical data on file. Results may not correlate to clinical outcomes.

2. C. R. Bard Inc., bench data on file.

3. Preclinical data on file. Results may not correlate to clinical outcomes.

4. Survey of surgeons attending an international surgical conference. Data on file.

Indications

The OptiFix™ Absorbable 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
  • Situations with insufficient ingrowth of tissue into the mesh over time, which could result in inadequate fixation 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 OptiFix™ Absorbable Fixation 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 structures. 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

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. After use, the OptiFix™ Absorbable Fixation System may be a potential biohazard. Handle and dispose of in accordance with any local and federal laws regarding medical waste.

Adverse Reactions

Adverse reactions and potential complications associated with fixation devices such as the OptiFix™ Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema and erythema at wound site; allergic reaction to Poly(D, L)- lactide; infection/septicemia; hernia recurrence/wound dehiscence.

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Specification

GTIN - each

00801741074325

1

GTIN - Case

10801741074322

5


Quantity

5/cs


Dimensions

OptiFix™ Absorbable Fixation System - 15 Absorbable Fasteners

GTIN

GTIN - each 00801741074325 1
GTIN - Case 10801741074322 5

Packaging

Quantity 5/cs

Product Basic Specification

Dimensions OptiFix™ Absorbable Fixation System - 15 Absorbable Fasteners
References
false
Electronic Instructions for Use (eIFUs)
Resources
References
false
Frequently Asked Questions
false
References
false
Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.

To better facilitate our investigation, please include the following information in your reporting:


  • Product Name and/or Catalog Number
  • Lot Number or Serial Number
  • Any injuries and/or Harm?
  • What is the issue you experienced?
  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
References
false
true