OTTO BOCK AXTION® PROSTHETIC FOOT

Additional Manufacturer Narrative

DEVICE NOT RETURNED. EVAL. FROM PHOTOS.

Description of Event or Problem

THE END-USER WAS USING THE AXTION FOOT WALKING ON LEVEL GROUND WHEN THE PYRAMID ADAPTER BROKE IN HALF. NO FALL OR INJURY OCCURED DURING THIS EVENT. ALTHOUGH THE CUSTOMER'S FOOT WAS BEYOND THE WARRANTY PERIOD, HE FELT INCLINED TO REPORT THE FOOT'S FAILURE. OUT OF AN ABUNDANCE OF CAUTION, THIS COMPLAINT WILL BE REPORTED AS AN MDR SINCE THE CONFIRMED DEVICE FAILURE IS KNOWN TO HAVE THE POTENTIAL TO CAUSE SERIOUS INJURY.