MalfunctionKGS
BIO-FASTAK SUTURE ANCHOR
Received Jun 1, 2006 · Event occurred May 1, 2006
Report 1220246-2006-00058 · MDR key 722151
Device
Generic name
Bio-absorbable Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
NACatalog number
AR-1324B
Lot number
57577
Product problems
- Device, or device fragments remain in patient
- Tip breakage
Patient
*
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
TIP OF SUTURE ANCHOR BROKE OFF DURING INSERTION. TIP REMAINS IN THE PT, HOWEVER, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.