ENDO DISSECT

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING USE, PART OF THE JAW WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THE JAW OF THE DEVICE WAS BROKEN AT THE FULCRUM. PMV PERFORMED FUNCTIONAL TESTING AND THE JAW ROTATED WITHOUT DIFFICULTY. OTHER FUNCTIONS OF DEVICE COULD NOT BE TESTED DUE TO CONDITION OF DEVICE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS DUE TO THE PRODUCT NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. REPLICATION OF THE BROKEN JAW MAY OCCUR WHEN THE DEVICE IS EXPOSED TO A SIDE FORCE (LEVERAGE) THAT CONSEQUENTLY BREAKS ONE SIDE OF THE JAWS. ANOTHER POSSIBILITY IS WHEN THE DEVICE IS ACTIVATED WITH TOO MUCH FORCE TO THE JAWS AND IS USED IN A TWISTING MOTION RESULTING IN BREAKAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.