DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG

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 # 01B1400057 WAS CONFIRMED WITH RECEIVED SAMPLE, DURING VISUAL INSPECTION WAS OBSERVED; RUBBER BANDS ARE BROKEN. FAILURE MODE ELASTICS BREAK EASILY REPORTED BY THE CUSTOMER WAS CONFIRMED DURING VISUAL INSPECTION. SAMPLE RECEIVED CONFIRMS THE DEFECT REPORTED BY THE CUSTOMER ELASTICS BREAK EASILY. A REVIEW WAS CONDUCTED OF THE IFU AND IT WAS FOUND THAT THE CUSTOMER IS DIRECTED TO "INSPECT EACH DURAHOOK AND DERMAHOOK PRIOR TO USE, SPECIFICALLY TO ENSURE THE INTEGRITY OF THE ELASTIC BAND. IF THE ELASTIC BAND CONTAINS TEARS, SPLITS OR OTHER DAMAGE, DO NOT USE." IN ADDITION, THIS DEFECT WAS FOUND AT INCOMING INSPECTION. 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

COMPLAINT ALLEGES THAT THE ELASTICS ATTACHED TO THE DURA HOOKS BREAK QUITE EASILY, AS IF DRIED. THE DURA HOOKS WERE OBSERVED TO BE DEFECTIVE IN THE SEALED PACKAGES. NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

(B)(4). DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. FAILURE MODE "ELASTICS BREAK EASILY" WAS UNABLE TO BE CONFIRMED WITH THE PHOTO THAT WAS RECEIVED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE PRODUCT SAMPLE NOT BEING AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. HOWEVER, WE WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

Description of Event or Problem

COMPLAINT ALLEGES THAT THE ELASTICS ATTACHED TO THE DURA HOOKS BREAK QUITE EASILY, AS IF DRIED. THE DURA HOOKS WERE OBSERVED TO BE DEFECTIVE IN THE SEALED PACKAGES. NO PT INJURY REPORTED.