MalfunctionGDG
DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG
Received Feb 24, 2015 · Event occurred Dec 18, 2014
Report 3004365956-2015-00170 · MDR key 4549598
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ALLEGED ISSUE: DURING A CRANIOTOMY, THE SCRUB NURSE PROCEEDED TO BEND THE PRODUCTION A SMALLER SIZE AND IT PROCEEDED TO BREAK. ANOTHER LOT NUMBER WORKED AND BENT WITHOUT BREAKING. THIS INCIDENT OCCURRED DURING INSPECTION/FUNCTIONALITY TESTING AND PRIOR TO USE ON A PATIENT.
Additional Manufacturer Narrative
THE DEVICE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER, HOWEVER, THE INVESTIGATION RESULTS HAVE NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.