OTTO BOCK AXTION® PROSTHETIC FOOT

Description of Event or Problem

INITIALLY AN S1 SERVICE NOTIFICATION WAS CREATED (500296911) FOR THE AXTION FOOT. THE CUSTOMER'S DESCRIPTION OF THE FAILURE STATED, "BROKEN ADAPTER". ADMINISTRATORS AT (B)(4) RETURNED THE FOOT TO (B)(4) ON (B)(6) 2019 WHICH REFLECTS THE ACTUAL REPORTABLE AWARENESS DATE FOR (B)(4). S1 500296911 WAS IMMEDIATELY CANCELLED AND S4 COMPLAINT NOTIFICATION WAS CREATED (600561556). AFTER FOLLOW UP WITH THE CUSTOMER AND END-USER, IT WAS DETERMINED THIS AXTION FOOT WAS USED WITHIN INDICATIONS AND THE FAILURE OCCURRED DURING NORMAL USE. NO FALL OR INJURY WAS REPORTED BY THE END-USER WHEN THIS FAILURE OCCURRED. IT COULD BE ARGUED THIS FOOT WAS USED BEYOND INTENDED USE LIFE BUT THAT CANNOT BE EXPLICITLY CONFIRMED WITH NO ON-BOARD STEP COUNTER IN THE MECHANICAL, CARBON FOOT. EVIDENCE ALSO CONFIRMS THE POSSIBILITY THIS FOOT WAS NOT RETURNED AS THE INSTRUCTIONS FOR USE RECOMMEND WHEN THE INITIAL SIGNS OF WEAR OCCURRED (FAILURE MODES 01.001 AND 04.001 ARE BOTH USER-FAULT). REGARDLESS, A KNOWN DESIGN CAUSE HAS BEEN CORRECTED FOR THIS FAILURE (B)(4) AND A NEWLY DESIGNED PYRAMID HAS BEEN IMPLEMENTED WITH ABSOLUTE SUCCESS IN THE MARKET TO DATE. 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.