inforMED
MalfunctionKGS

BIO MINI-REVO SUTURE ANCHOR

Received Jul 27, 2006

Report 1017294-2006-00292 · MDR key 752814

Device

Generic name

Suture Anchor

Model number

NA

Catalog number

C6170H

Lot number

UNK

Product problems

  • Break
  • Difficult to Insert
  • Replace
  • Device, removal of (non-implant)

Patient

UNKNOWN

  • Foreign body, removal of

Narrative

Additional Manufacturer Narrative

TO DATE, THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. IF FURTHER INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT. THIS PRODUCT WILL CONTINUE TO BE MONITORED. THE CUSTOMER WILL BE CONTACTED BY THE SALES REP TO PROVIDE ANY ADD'L INSERVICING NEEDS FOR THIS PRODUCT.

Description of Event or Problem

IT WAS REPORTED THAT DURING A BANKART REPAIR, THE BIO MINI-REVO SUTURE ANCHOR BROKE DURING INSERTION AND WAS RETRIEVED. AN ALTERNATE ANCHOR WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY OR DELAY RELATED TO THIS EVENT.