InjuryKGS
BIO-FASTAK SUTURE ANCHOR
Received Jun 22, 2004 · Event occurred Apr 30, 2004
Report 1220246-2004-00044 · MDR key 530807
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
AR-1324BF-2Catalog number
AR-1324BF-2
Lot number
35559
Product problems
- Device remains implanted
- Replace
- Device Issue
Patient
*
- Surgical procedure aborted/stopped
Narrative
Description of Event or Problem
CUSTOMER CLAIMS THAT THE BIO SUTURE ANCHOR IMPLANT USED IN 2004 WOULD NOT BITE INTO BONE AND PULLED OUT. THIS WAS THE SECOND DEVICE BEING USED FOR THIS PT DURING THE PROCEDURE. FURTHER INFORMATION OBTAINED FROM THE CUSTOMER INDICATES THE PROCEDURE WAS COMPLETED WITH A TITANIUM IMPLANT. NO FURTHER COMPLICATIONS RELATED TO THE EVENT HAVE BEEN REPORTED TO THIS DATE. THIS DEVICE IS USED FOR TREATMENT. THE FIRST DEVICE USED ON THIS PT, "BROKE ON INSERTION" AND WAS REPORTED UNDER MDR REPORT # 1220246 2004 00043.
Remedial action
- Other