MalfunctionKGS
PRELOADED MINI-REVO ANCHR
Received Jun 25, 1998 · Event occurred May 26, 1998
Report 1017294-1998-00024 · MDR key 174848
Device
Product problems
- Break
- Device, or device fragments remain in patient
- Difficult to Remove
- Replace
- Suture line separation
Patient
Not reported
- Surgery, prolonged
- Nonresorbable materials, unretrieved in body
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION - THE HEX PROXIMAL TIP, WHICH WAS DETACHED AT THE SUTURE EYELET OPENING, WAS RETURNED FOR EVAUATION. IT APPEARS TO HAVE FAILED DUE TO EXCESSIVE TORSIONAL OVERLOAD. THIS MAY HAVE OCCURRED DUE TO PARTIAL DRIVER ENGAGEMENT DURING INSERTION.