WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG
Received Sep 10, 2013 · Event occurred Jul 19, 2013
Report 3003898360-2013-00387 · MDR key 3393398
Device
Product problems
- Break
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: PER MEDWATCH REPORT: "DERMA HOOK BROKE DURING CLOSURE OF THE GALEA APONEUROTICA. THE SHAFT WAS RETRIEVED AND ANOTHER DERMA HOOK WAS USED TO COMPLETE THE CASE. THERE WAS A SMALL DELAY WHILE THE SECOND DEVICE WAS OBTAINED. NO APPARENT PATIENT HARM." NO PATIENT INJURY REPORTED. PATIENT CURRENT CONDITION IS FINE.
Additional Manufacturer Narrative
PER DEVICE HISTORY REPORT (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.