MalfunctionKGS
CORKSCREW FT 11 SUTURE ANCHOR W/2 FIBURWIRE
Received Apr 17, 2007 · Event occurred Apr 17, 2007
Report MW1042634 · MDR key 840654
Device
Product problems
- Component(s), broken
Patient
*
- Surgery, prolonged
- Surgical procedure, additional
Narrative
Description of Event or Problem
PHYSICIANS INSERTED FIVE OF THESE ANCHORS INTO THE RIGHT SHOULDER. AS THEY WERE TIED DOWN THE FIBERWARES BROKE. REQUIRED THE PROCEDURE TO GO FROM ARTHROSCOPIC TO AN OPEN PROCEDURE AND INCREASED THE SURGERY TIME TWO FOLD. RETAINING PRODUCT IN THE SAME LOT HAVE BEEN SEQUESTERED.