inforMED
MalfunctionKGS

BIO MINI REVO SUTURE ANCHOR, PRELOADED

Received Jun 28, 2006 · Event occurred May 26, 2006

Report 1017294-2006-00219 · MDR key 734362

Device

Generic name

Suture Anchor

Model number

NA

Catalog number

C6170H

Lot number

BBC48122

Product problems

  • Break
  • Material Frayed
  • Device Maintenance Issue
  • Replace

Patient

UNKNOWN

  • Surgery, prolonged

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING USE IN A SHOULDER SURGERY, THE ANCHOR WOULD NOT HOLD AND THE SUTURE ON THE DEVICE BROKE/FRAYED. THE SURGICAL CASE WAS DELAYED AS A RESULT AND THE SURGERY WAS COMPLETED WITH AN ALTERNATE DEVICE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PT.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: UNABLE TO VERIFY CUSTOMER'S REPORTED PROBLEM WITH THE PRODUCT AS IT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF PRODUCT HISTORY SHOWS NO OTHER CUSTOMER COMPLAINTS FOR THIS PRODUCT. AN INVESTIGATION OF UNUSED PRODUCT WITH THE SAME LOT NUMBER FOUND NO DISCREPANCIES. THE CUSTOMER WILL BE CONTACTED TO PROVIDE FURTHER INFO REGARDING THIS PRODUCT. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR PROBLEMS.