MalfunctionKGS
BIOFASTAK SUTURE ANCHOR WITH #2 FIBERWIRE
Received Jun 14, 2005 · Event occurred May 6, 2005
Report 1220246-2005-00095 · MDR key 638955
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
AR-1324BFCatalog number
AR-1324BF
Lot number
42860
Product problems
- Detachment Of Device Component
- Device remains implanted
- Replace
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AFTER IMPLANT WAS INSERTED AND WAS FULLY SEATED, THE SURGOEN PULLED ON SUTURES TO CHECK PURCHASE. THE EYELET PULLED OUT OF THE ANCHOR. SURGEON USED A METAL CORKSCREW TO COMPLETE. NO ADVERSE CONSEQUENCES REPORTED WITH THE PATENT AS A RESULT OF EVENT. THIS DEVICE IS USED FOR TREATMENT.