MalfunctionKGS
BIO MINI-REVO SUTURE ANCHOR, PRELOADED
Received Aug 31, 2007 · Event occurred Aug 8, 2007
Report 1017294-2007-00631 · MDR key 906175
Device
Generic name
Suture Anchor
Manufacturer
Conmed LinvatecModel number
NACatalog number
C6170H
Lot number
BBD03373
Product problems
- Device remains implanted
- Material Separation
Patient
44 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: TO DATE, THE INVESTIGATION IS STILL IN PROCESS. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE PRODUCT EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT DURING A BANKART LESION REPAIR, AFTER INSERTION OF THE IMPLANT THE SUTURE CAME OUT WITH THE APPLICATOR. THERE WAS NO REPORT OF INJURY OR SURGICAL DELAY WITH THIS EVENT.