MalfunctionEJB
MINIATURE PIN & LIGATURE CUTTER
Received Aug 17, 2011
Report 2086211-2011-00005 · MDR key 2264973
Device
Product problems
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT THE TIP OF A MINIATURE PIN AND LIGATURE CUTTER SEPARATED OUTSIDE OF A PT'S MOUTH; THERE IS NO INDICATION THAT INJURY RESULTED.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVAL AND WAS FOUND TO HAVE EXCEEDED THE EXPECTED LIFE OF THE DEVICE. WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT REC'D IN PAST TWO YRS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.