OtherKGS
BIO-SUTURETAK SUTURE ANCHOR WITH #2 FIBERWIRE
Received Jan 31, 2005 · Event occurred Jan 18, 2005
Report 1220246-2005-00014 · MDR key 570220
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
AR-1934BFCatalog number
AR-1934BF
Lot number
43787
Product problems
- Detachment Of Device Component
- Device remains implanted
- Replace
Patient
*
- Surgery, prolonged
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
ALL SUTURE TAKS FAILED DUE TO FIBERWIRE SUTURE FLOATING FREE OF SUTURE EYELET AFTER TIED IN TISSUE. IMPLANTS WERE FULLY SEATED (INTACT) AND NOT REMOVED FROM THE PT. THREE ADDITIONAL IMPLANTS WERE USED TO COMPLETE THE SLAP REPAIR. SURGERY WAS DELAYED 1 HOUR. NO ADVERSE CONSEQUENCES WERE REPORTED WITH THE PT DUE TO EVENT. THIS DEVICE IS USED FOR TREATMENT.