MalfunctionGDG
WECK DURAHOOK 1/4"
Received Aug 3, 2012 · Event occurred Jun 7, 2012
Report 3003898360-2012-00291 · MDR key 2684893
Device
Product problems
- Break
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: THE DEVICE WAS BRITTLE AND BREAKING WHEN THE CURVATURE WAS BEING RESHAPED; WHICH IS A COMMON PRACTICE WITH THIS DEVICE. UNK WHEN ALLEGED DEFECT WAS FOUND. NO PT INJURY REPORTED.
Additional Manufacturer Narrative
DEVICE SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. NO ACCURATE LOT NUMBER WAS PROVIDED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.