{"AlternateComparison":false,"RelatedProducts":false,"Specification":true,"FeatureBenefit":false}
OptiFix™ OptiFix™ AT Absorbable Fixation System with Articulating Technology

OptiFix™ AT Absorbable Fixation System, 30 Absorbable Fasteners

Icon to close the modal
Support
Sales
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Modal Close Icon

Capability:

Product Line:

Icon to close thank you modal
Thank you for contacting our sales team!
A sales representive will get in touch with you shortly.
Ordering
Phone Icon
1.800.556.6756
BDISurgery@bd.com
Onsite Visiting
Location Icon
100 Crossings BoulevardWarwick, Rhode Island 02886United States
Customer Service
Phone Icon
1.844.8.BD.LIFE (1.844.823.5433)
Monday to Friday 8:15 AM to 6:00 PM EST
Fax Icon
1.800.531.4124
Custserv.davol@bd.com
Shipping a Product Back
Location Icon
100 Crossings Boulevard, Warwick, Rhode Island 02886, United States
Overview

OptiFix™ AT Is on articulating device that allows for traditional straight fixation plus the option to articulate the tip to better access areas where mesh fixation may otherwise be difficult, such as locations close to the trocor.

The ergonomic device is designed to:1

  • Provide full mesh access from one side of the patient.
  • Deliver more consistent perpendicular fastener deployment.
  • Enhance surgeon comfort.
true
Features and Benefits
Promotional Story
false
References

Indications

OptiFix™ AT Absorbable Fixation System with Articulating Technology 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

Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply, including but not limited to:

  • Fixation in the close vicinity of underlying structures such as nerves, vessels, viscera, cartilage or bone. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera, cartilage or bone. For reference, the length of the fastener below the fastener head is 6.5 mm, and the fastener head is another 0.6 mm (total 7.1 mm).
  • Fixation of or in proximity to 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.
  • Fixation of vascular or neural structures, viscera, cartilage or bone.
  • Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is absorbed.

Warnings

Remove the yellow clip prior to use of device. Do not use device if the yellow clip is damaged or not in place. 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™ AT Absorbable Fixation System with Articulating Technology may be a potential biohazard. Handle and dispose of in accordance with any local and federal laws regarding medical waste.

Adverse Reactions

Potential complications with the use of any prosthesis may include, but are not limited to hemorrhage; pain, erosion, edema and erythema at wound site; allergic reaction to poly(L-lactide-co-glycolide); septicemia/infection; hernia recurrence/wound dehiscence.

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.

1. Preclinical data on file at BD. Results may not correlate to performance in humans.

true
Specification

GTIN - Case

10801741136563

5

GTIN - each

00801741136566

1


Quantity

5 c/s.


Dimensions

OptiFix™ AT Absorbable Fixation System - 30 absorbable fasteners

GTIN

GTIN - Case 10801741136563 5
GTIN - each 00801741136566 1

Packaging

Quantity 5 c/s.

Product Basic Specification

Dimensions OptiFix™ AT Absorbable Fixation System - 30 absorbable fasteners
References
false
Electronic Instructions for Use (eIFUs)
Resources
References
false
Frequently Asked Questions
false
References
false
Related Products
RELATED PRODUCTS NOT AVAILABLE
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
Product Recalls
Literature Icon
Recall Notifications
These recall notices provide current information on medical device recalls.
Learn more
References
false
false