BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3009495988-2015-00005

    MDR report key: 5141800 · Received October 7, 2015

    Report

    Report Number
    3009495988-2015-00005
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    August 25, 2015
    Report Date
    September 24, 2015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE WAS UNDER-TORQUED (PRELOAD) FASTENERS AND LOSS OF JOINT TENSION DUE TO THE DEGENERATIVE COMPRESSION OF THE CARBON FIBER FOOTPLATE. REMEDIAL ACTION: A BEARING PLATE WILL BE PLACED BETWEEN THE CARBON FIBER FOOTPLATE AND ANKLE BOX, AND WASHERS WILL BE PLACED UNDER THE FASTENERS ALONG WITH THREAD LOCKER. SINCE THIS FAILURE MODE REPRESENTS A LOW RISK OF INJURY THE CORRECTIVE ACTIONS WILL BE MADE AT THE NEXT ROUTINE SERVICE PERIOD.

    Additional Manufacturer Narrative · 1

    DEVICE TO BE RETURNED TO MFR FOR EVAL. BASED ON PREVIOUS SIMILAR MALFUNCTIONS, MFR DETERMINED THAT FASTENERS SHEARED UNDER BENDING STRESSES GREATER THAN THE FATIGUE LOAD OF THE FASTENER (B)(4) CAUSING THE FOOT PLACE TO PARTIALLY SEPARATE FROM THE ANKLE ((B)(4)). FAILURE MODE OF FASTENERS WAS FROM BENDING FATIGUE, HOWEVER ROOT CAUSE ANALYSIS OF FAILURE MODE IS STILL UNDER INVESTIGATION AND RESULTS ARE PENDING COMPLETION OF EVAL. ADDITIONAL INFO FOLLOW-UP WILL BE SUBMITTED WHEN THE FOLLOWING INFO BECOMES AVAILABLE: THIS DEVICE IS CURRENTLY REGISTERED UNDER PROCODE BXB AS INDICATED. THIS DEVICE IS CURRENTLY PENDING 510 (K) APPROVAL UNDER PROCODE PHL. EVAL RESULTS AND CONCLUSION - AS ROOT CAUSE ANALYSIS IS STILL PENDING EVAL. REMEDIAL ACTION - ROOT CAUSE ANALYSIS IS STILL PENDING EVAL. NOTE TO FDA: MDR PREPARED BY DEADLINE, BUT SUBMITTED PAST DEADLINE DATE SINCE PRODUCTION WEBTRADER ACCOUNT IS STILL PENDING ACTIVATION.

    Description of Event or Problem · 1

    THIS EVENT DID NOT LEAD TO AN INJURY AND THERE HAVE BEEN NO INJURIES REPORTED SINCE THE MDR WAS FILED.

    Description of Event or Problem · 1

    [DEVICE #4 SIMILAR TO MDR # 3009495988-2015-00001]. CUSTOMER REPORTED THAT THE MALFUNCTION OCCURRED WHILE WALKING. PHYSICAL THERAPIST NOTICED THAT THE FOOT PLATE HAD COME PARTIALLY SEPARATED FROM THE DEVICE. PHYSICAL THERAPIST WAS ABLE TO LOWER THE PT INTO A CHAIR AND WAS SAFELY REMOVED FROM THE DEVICE. THE PT SUSTAINED NO INJURIES AND NO MEDICAL FOLLOW-UP OR INTERVENTION WAS NEEDED. NO PHYSICAL THERAPISTS, THERAPISTS, OR THIRD PERSONS HAVE BEEN AFFECTED OR INJURED.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR