BIO-MINI REVO SUTURE ANCHOR
Received Jun 22, 2006 · Event occurred May 22, 2006
Report 1017294-2006-00197 · MDR key 731610
Device
Generic name
Suture Anchor
Manufacturer
Conmed Linvatec Corp.Model number
NACatalog number
C6170H
Lot number
BBC48122
Product problems
- Break
- Difficult to Insert
- Device remains implanted
- Device, or device fragments remain in patient
- Replace
Patient
UNKNOWN
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING INSERTION OF AN IMPLANT FOR A SUPERIOR LABRUM ANTERIOR - POSTERIOR REPAIR (SLAP), THE IMPLANT BROKE IN HALF. THE BROKEN IMPLANT WAS LEFT IN THE PATIENT . IN ADDITION, ANOTHER IMPLANT WAS INSERTED TO COMPLETE THE SURGERY. NO INJURY OR DELAY WAS REPORTED.
Additional Manufacturer Narrative
NO MEDWATCH RECEIVED FROM USER FACILITY. ALL SECTIONS ON THIS FORM COMPLETED BY MANUFACTURER. INVESTIGATION RESULTS: THE DRIVER AND PART OF THE IMPLANT WAS RETURNED FOR INVESTIGATION. THE PROXIMAL END OF THE ANCHOR WAS FOUND ROTATED FROM ITS ORIGINAL POSITION. IN ADDITION, THE SUTURES WERE FOUND TWISTED INSIDE THE DRIVER. THE INHERENT VISCOSITY OF THE IMPLANT MATERIAL WAS FOUND TO BE WITHIN ACCEPTED LIMITS. FURTHER INVESTIGATION FOR THIS FAILURE MODE IS IN PROCESS.