WECK EFX SHIELD PORT SITE CLOSURE SYSTEM

Additional Manufacturer Narrative

(B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "AN EVALUATION OF THE RETURNED UNIT CONFIRMED THE FAILURE MODE OBSERVED BY THE CUSTOMER, WHICH WAS A BROKEN HINGE AS INDICATED IN THE ATTACHED PICTURE. SPECIFICALLY, THE HINGE FAILED NEAR THE WELD LOCATION IN THE MIDDLE OF THE DEVICE. IT SHOULD BE NOTED THAT 100% OF ALL DEVICES MANUFACTURED GO THROUGH TESTING FOR THE APPROXIMATION WING HINGE INTEGRITY AND BOTH SIDES MUST PASS (NOT BREAK) FOR THE DEVICE TO BE CONSIDERED ACCEPTABLE. DEVICES THAT DO NOT PASS BOTH SIDES ARE REJECTED. ADDITIONALLY, ALL SUBSEQUENT FUNCTIONAL TESTING WOULD NOT HAVE BEEN ABLE TO BE PERFORMED. SINCE THE DEVICES RECEIVE 100% IN-LINE TESTING FOR BOTH HINGE INTEGRITY AND FUNCTIONAL PERFORMANCE, THE COMPLAINT IS CONSIDERED VERIFIED, BUT NOT A PARAGON MEDICAL FAILURE AS THE FAILURE COULD NOT HAVE OCCURRED PRIOR TO RELEASE FROM MANUFACTURING. A REVIEW OF THE DHR SHOWED THAT THERE WERE NO NONCONFORMANCES NOTED. A REVIEW OF THE DHR SHOWED THAT THERE WERE NO MANUFACTURING ABNORMALITIES NOTED. NO CONTAINMENT ACTIVITY REQUIRED AS THIS ISSUE IS INHERENT TO THE DESIGN OF THE HINGE. ADDITIONALLY, THERE IS AN IN -PROCESS INSPECTION FOR ALL DEVICES. A REVIEW OF THE MEI CONFIRMS THAT THE OPERATORS ARE REQUIRED TO PERFORM AN INSPECTION ON ALL DEVICES TO VERIFY THAT THE WINGS ARE NOT BROKEN. OPERATOR FEEDBACK CONFIRMED THAT ALL UNITS ARE BEING TESTED AND THAT THERE ARE NO ISSUES WITH PERFORMING THE TEST." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

Description of Event or Problem

IT WAS REPORTED THAT "SHIELD CLOSURE DEVICE PREPPED AS NORMAL AND USED FOR FASCIAL CLOSURE OF A PATIENT. WHILE INTO ABDOMEN, IT BROKE, BUT NOT APART. SHIELD WAS INTACT AND REMOVED CAREFULLY. NO HARM TO PATIENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE SHIELD BROKE INSIDE THE ABDOMEN, BUT NOT APART-THIS OCCURRED DURING THE WING FIXTURE PHASE. THE SHIELD WAS PROPERLY REMOVED WITHOUT ANY PARTS FALLING OFF IT". ANOTHER SHIELD DEVICE WAS OPENED AND USED AS INTENDED.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "SHIELD CLOSURE DEVICE PREPPED AS NORMAL AND USED FOR FASCIAL CLOSURE OF A PATIENT. WHILE INTO ABDOMEN, IT BROKE, BUT NOT APART. SHIELD WAS INTACT AND REMOVED CAREFULLY. NO HARM TO PATIENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE SHIELD BROKE INSIDE THE ABDOMEN, BUT NOT APART-THIS OCCURRED DURING THE WING FIXTURE PHASE. THE SHIELD WAS PROPERLY REMOVED WITHOUT ANY PARTS FALLING OFF IT". ANOTHER SHIELD DEVICE WAS OPENED AND USED AS INTENDED.