OTTO BOCK AXTION® PROSTHETIC FOOT

Additional Manufacturer Narrative

SUBMISSION WAS ORIGINALLY ATTEMPTED ON 11/13/2018. IT WAS DISCOVERED ON 11/13/2018 THAT THE ORIGINAL SUBMISSION WAS NOT ACCEPTED DUE USE OF AN INCORRECT ICSR VERSION. ICSR R2 IS NOW REQUIRED. I RE-INSTALLED ESUBMITTER IN HOPES THE PROBLEM IS RESOLVED AND MY SUBMISSION WILL BE ACCEPTED. THE CDRH EMDR HELP DESK SUGGESTED THE RE-INSTALLING OF THE ESUBMITTER WOULD RESOLVE THIS ISSUE. (B)(4).

Description of Event or Problem

THE END-USER WAS WALKING INTO A MOVIE THEATRE AND HEARD A CRACK. IMMEDIATELY THE END-USER REALIZED THE PYRAMID ADAPTER HAD CRACKED CAUSING THE FOOT TO BECOME DISCONNECTED FROM THEIR PYLON. THE END-USER AVOIDED FALLING AND WAS ABLE TO GET BACK TO HIS HOME SAFELY. HE USED A BACK UP FOOT UNTIL HIS AXTION FOOT WAS REPLACED. NO FALL OR INJURY RESULTED. ALL INFORMATION REPORTED BY THE CUSTOMER AND END-USER INDICATES 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.