OtherKGS
BIO-FASTAK SUTURE ANCHOR WITH #2 FIBERWIRE
Received Jun 28, 2007 · Event occurred May 14, 2007
Report 1220246-2007-00117 · MDR key 871822
Device
Generic name
Bio-absorbable Suture Anchor
Manufacturer
Arthrex, Inc.Model number
NACatalog number
AR-1324BF
Lot number
80375
Product problems
- Break
- Difficult to Insert
- Device, or device fragments remain in patient
Patient
YR
- Nonresorbable materials, unretrieved in body
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. DHR REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. ARTHREX WILL CONTINUE TO INVESTIGATE THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH SIGNIFICANT INFO OBTAINED FROM THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE IMPLANT BROKE AT THE HEX ON INSERTION. THE BROKEN PIECE REMAINS IN THE PT, HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.