MalfunctionKGS
LINVATEC
Received Oct 21, 2003 · Event occurred Oct 8, 2003
Report MW1029854 · MDR key 492550
Device
Generic name
Duet Suture Anchor
Manufacturer
Linvatec CorpModel number
REF BX54216Catalog number
6.0 X 16.5 MM
Lot number
50001169
Product problems
- Device Issue
- Device, removal of (non-implant)
Patient
43 YR
- Surgical procedure aborted/stopped
Narrative
Description of Event or Problem
DURING SHOULDER SURGERY CASE THE DR -USING APROPRIATE DRILL BIT- DRILLED A HOLE IN THE BONE OF THE SHOULDER AND ATTEMPTED TO INSERT A DUET ANCHOR. UPON PLACING THE ANCHOR HALF WAY INTO THE BONE, THE DEVICE FAILED AND HAD TO BE REMOVED. ATTEMPTED AGAIN USING A NEW DRILL BIT AND THE NEW DEVICE FAILED. BOTH ANCHORS WERE REMOVED AND OTHERS WERE PLACED WITHOUT DIFFICULTY.