DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
Received Apr 29, 2015 · Event occurred Mar 12, 2015
Report 3003898360-2015-00315 · MDR key 4743012
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
EVENT REPORTED, AS THE FOLLOWING: INTRA-OPERATIVELY TWO DERMA HOOKS THAT WERE RETRACTING THE GALEA "SNAPPED" IN HALF IN SUCCESSION ON THE FIELD. ALL PIECES FROM OPERATIVE FIELD WERE RETRIEVED AND REMOVED. NO PT INJURY REPORTED. (B)(4).
Additional Manufacturer Narrative
QN# (B)(4). DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED SINCE IT IS NECESSARY TO REC'D THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME, DUE TO THE LACK OF DEFECTIVE PROD, IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT AND TO DETERMINE THE ROOT CAUSE. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.