ULTRAFIX RC STITCHPAK, DOUBLE SUTURE, 2.9MM
Received Jan 23, 2008 · Event occurred Dec 26, 2007
Report 1017294-2008-00084 · MDR key 986085
Device
Product problems
- Break
- Difficult to Insert
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING INSERTION OF THIS SUTURE ANCHOR IN A QUADRICEP REPAIR, IT BROKE BEFORE IT COULD BE SEATED IN THE PATELLA. THE USER REPORTED DRILLING A PILOT HOLE PRIOR TO INSERTION. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC WAS UNABLE TO CONFIRM THE REPORTED PROBLEM BECAUSE THE SUTURE ANCHOR WAS DISCARDED BY THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT INDICATE THAT THE DEVICE IS INTENDED FOR USE IN ROTATOR CUFF REPAIRS AND CONTRAINDICATES SURGICAL PROCEDURES OTHER THAN THOSE LISTED IN THE INDICATIONS FOR USE. THE CUSTOMER WILL BE PROVIDED ADD'L INFO ON THE USE OF THIS DEVICE. THE USER REPORTED USING A TOTAL OF SEVEN ANCHORS IN THIS PROCEDURE, FOUR OF WHICH WERE SUCCESSFULLY IMPLANTED. THE OTHER REPORT NUMBERS ASSOCIATED WITH THIS EVENT ARE: 1017294-2008-00029, 1017294-2008-00030.