InjuryKGS
BIO-FASTAK SUTURE ANCHOR
Received Jun 22, 2004 · Event occurred Apr 30, 2004
Report 1220246-2004-00043 · MDR key 530800
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
AR-1324BF-2Catalog number
AR-1324BF-2
Lot number
35559
Product problems
- Break
- Device, or device fragments remain in patient
- Replace
Patient
*
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
CUSTOMER CLAIMS THAT THE BIO SUTURE ANCHOR IMPLANT USED IN 2004 BROKE UPON INSERTION AT THE SHOULDER-LABRUM AREA. FURTHER INFORMATION OBTAINED FROM THE CUSTOMER INDICATES NO ATTEMPT WAS MADE TO RETRIEVE THE INSERTED PIECE AND 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 SECOND DEVICE USED "WOULD NOT BITE" AND WAS RETRIEVED. REFER TO MDR REPORT # 1220246 2004 00044 FOR THE DEVICE EVALUATION.
Remedial action
- Other