DURAHOOK 1/4 HOOK
Received Jul 30, 2015 · Event occurred Jul 17, 2015
Report 3003898360-2015-00546 · MDR key 4952602
Device
Product problems
- Degraded
Patient
Not reported
- Not Applicable
Narrative
Additional Manufacturer Narrative
(B)(4). ONE (1) POUCH FROM P/N 382800 DURAHOOK 1/4 HOOK (B)(4) WAS RECEIVED NOT USED , CLOSED IN ORIGINAL PACKAGING, LOT # 73M1400048 WAS CONFIRMED WITH RECEIVED SAMPLE, DURING VISUAL INSPECTION COMPONENTS LOOKED WELL ASSEMBLED, RUBBER BANDS DID NOT APPEAR TO HAVE DAMAGE. FUNCTIONAL INSPECTION: POUCH WAS OPENED TO REVIEW THE RUBBER BANDS CONDITIONS (UNDAMAGED), THEN RUBBER BANDS WERE FASTENED TO A PAPERBOARD, AFTER RUBBER BANDS WERE STRETCHED TO FULL CAPACITY , NO QUALITY ISSUES WERE FOUND DURING FUNCTIONAL TESTING (RUBBER BANDS WERE NOT BROKEN), THEREFORE FAILURE MODE DRY ROT REPORTED BY CUSTOMER WAS NOT ABLE TO BE DUPLICATED. SAMPLE RECEIVED DID NOT CONFIRM THE DEFECT REPORTED BY THE CUSTOMER "DRY ROT." A FUNCTIONAL INSPECTION WAS PERFORMED AND THE DEVICE WORKED PROPERLY; NOT BROKEN. THEREFORE, A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. HOWEVER, WE WILL CONTINUE TO MONITOR TRENDING OF SIMILAR COMPLAINTS.
Description of Event or Problem
ALLEGED EVENT: THE DURAHOOKS ARE DRY ROTTING WHICH IS EVIDENT THROUGH THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG, LOT NUMBER 73M1400048 DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
ALLEGED EVENT: THE DURAHOOKS ARE DRY ROTTING WHICH IS EVIDENT THROUGH THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.