OTTO BOCK AXTION® PROSTHETIC FOOT

Description of Event or Problem

IT WAS REPORTED BY THE END-USER'S FACILITY THAT, "PYRAMID BROKE - CRACKED AT THE BOLTS." AFTER MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION, THE CUSTOMER WAS NON-RESPONSIVE. NO INFORMATION IS KNOWN ABOUT HOW THE FOOT WAS USED, EVENTS LEADING UP TO THE FAILURE, AND IF ANYTHING SIGNIFICANT RESULTED AFTER THE FAILURE OCCURRED. THE FAILURE DID OCCUR WITHIN THE INTENDED USE LIFE OF THE SPECIFIED FOOT. OUT OF AN ABUNDANCE OF CAUTION, THIS COMPLAINT IS BEING REPORTED AS AN MDR SINCE THE CONFIRMED FAILURE HAS HISTORICALLY CAUSED SERIOUS INJURY TO AN END-USER.