OTTO BOCK AXTION® PROSTHETIC FOOT

Additional Manufacturer Narrative

[(B)(4)].

Description of Event or Problem

IT WAS REPORTED BY THE END-USER'S FACILITY THAT THE END-USER WAS SIMPLY PERFORMING NORMAL DAILY ACTIVITIES. WHILE WALKING, THE END-USER HEARD A POP AND OBSERVE THAT HIS AXTION FOOT PYRAMID HAD CRACKED THROUGH. NO FALL OR INJURY RESULTED FROM THE AXTION PYRAMID FAILURE. THEREFORE, NO MEDICAL ATTENTION WAS SOUGHT AFTER THIS FAILURE. THE AXTION FOOT COULD NO LONGER BE USED AND THE DEFECT WAS REPORTED TO OTTOBOCK ONE WEEK AFTER THE EVENT. ALL INFORMATION REPORTED BACK FROM THE END-USER'S FACILITY CONFIRMED THAT THE FOOT WAS USED AS INSTRUCTED AND WITHIN PROPER INDICATIONS. THE FAILURE OCCURRED WITHIN THE INTENDED USE-LIFE FOR THIS DEVICE. OUT OF AN ABUNDANCE OF CAUTION, THIS COMPLAINT IS BEING REPORTED AS AN MDR SINCE THIS CONFIRMED FAILURE HAS DEMONSTRATED THE RISK OF CAUSING SERIOUS INJURY TO THE END-USER.