BIO MINI-REVO SUTURE ANCHOR
Received Nov 20, 2006 · Event occurred Oct 31, 2006
Report 1017294-2006-00481 · MDR key 791147
Device
Generic name
Suture Anchor
Manufacturer
Conmed LinvatecModel number
NACatalog number
C6170H
Lot number
BBC64967
Product problems
- Break
- Replace
- Implant, removal of
Patient
UNKNOWN
- Surgical procedure
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING A LABRAL REPAIR, THE BIO MINI-REVO IMPLANT BROKE DURING INSERTION JUST BELOW THE EYELET. THE SURGEON REMOVED THE IMPLANT AND INSERTED ANOTHER ONE IN THE SAME PILOT HOLE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO INJURY TO THE PATIENT.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: THE BIO MINI-REVO IMPLANT WAS RECEIVED FOR EVALUATION WITHOUT THE BROKEN PORTION. DURING A VISUAL EXAMINATION OF THE DEVICE, THE ANCHOR WAS FOUND BROKEN INSIDE THE DRIVER. THE INFORMATION FOR USE (IFU) PROVIDES USER INFORMATION REGARDING BREAKAGE. PROPER ORIENTATION AND ALIGNMENT OF INSTRUMENTS IS IMPORTANT DURING IMPLANTATION OF THE BIO MINI-REVO TO MINIMIZE POSSIBLE BREAKAGE OF THE ANCHOR. BREAKAGE OF THE BIO MINI-REVO IS POSSIBLE IF: THE PILOT HOLE IS NOT DRILLED TO AN ADEQUATE DEPTH. THE TAP IS NOT INSERTED TO THE PROPER DEPTH. IMPROPER ALIGNMENT OF ANCHOR TO PILOT HOLE. LOOSE OR NON-SECURE ANCHOR ON DRIVER. IT IS NOT USED WITH A BIO MINI-REVO DRILL GUIDE. THE ANCHOR INSERTER IS USED FOR PRYING. THE BIO MINI-REVO IMPLANT IS ADVANCED TOO DEEP.