OTTO BOCK AXTION® PROSTHETIC FOOT

Description of Event or Problem

THE CUSTOMER REPORTED THE END-USER WAS WALKING WHEN THE PYRAMID ADAPTER ON THEIR AXTION FOOT CRACKED. THE PYRAMID FAILURE CAUSED THE END-USER TO BECOME DETACHED FROM THEIR FOOT WHICH RESULTED IN A FALL. THE FALL CAUSED MINOR PAIN IN THE HAND AND SHOULDER FOR THE END-USER. OUTPATIENT MEDICAL CARE WAS SOUGHT, BUT NO FURTHER MEDICAL ATTENTION WAS REQUIRED OR REPORTED BY THE END-USER. BASED ON PURCHASE DATE OF THIS AXTION FOOT, IT IS VERY LIKELY THE FOOT WAS AT OR VERY NEAR ITS INTENDED LIFE PER ISO 10328 TESTING. ALTHOUGH THIS SPECIFIC OCCURRENCE DID NOT RESULT IN PERMANENT IMPAIRMENT FOR THE END-USER, THE CONFIRMED PYRAMID FAILURE IS KNOWN TO HAVE THE POTENTIAL TO CAUSE SERIOUS INJURY AND THEREFORE WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION.