MalfunctionKGS
STATAK SUTURE ANCHOR WITH ATTACHED SUTURE
Received Mar 2, 2012 · Event occurred Jan 31, 2012
Report 1822565-2012-00435 · MDR key 2501789
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT THE SUTURE WAS CUT AT THE HOLE OF ANCHOR DURING USE.