MalfunctionKGS
BIO MINI-REVO SUTURE ANCHOR
Received Jul 27, 2006
Report 1017294-2006-00291 · MDR key 753154
Device
Generic name
Suture Anchor
Manufacturer
Conmed Linvatec CorporationModel number
NACatalog number
C6170H
Lot number
UNK
Product problems
- Break
- Difficult to Insert
- Replace
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
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.
Additional Manufacturer Narrative
TO DATE, THIS PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT. THIS PRODUCT WILL CONTINUE TO BE MONITORED. THE CUSTOMER WILL BE CONTACTED BY THE SALES REPRESENTATIVE TO PROVIDE ANY ADDITIONAL INSERVICING NEEDS FOR THIS PRODUCT.