BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3009495988-2015-00004

    MDR report key: 5057614 · Received September 2, 2015

    Report

    Report Number
    3009495988-2015-00004
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 5, 2015
    Report Date
    September 2, 2015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 WAS RETURNED TO MANUFACTURER FOR EVALUATION AND WAS RETAINED. MANUFACTURER DETERMINED THAT FASTENERS SHEARED UNDER BENDING STRESSES GREATER THAN THE FATIGUE LOAD OF THE FASTENER CAUSING THE FOOT PLATE TO SEPARATE FROM THE ANKLE. 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 EVALUATION. ADDITIONAL INFO FOLLOW-UP WILL BE SUBMITTED WHEN THE FOLLOWING INFO BECOMES AVAILABLE: MDR SUBMITTED VIA PAPER ON DEADLINE DATE INSTEAD OF DIGITALLY VIA WEBTRADER SINCE PRODUCTION ACCOUNT IS STILL PENDING ACTIVATION. (D2B) THIS DEVICE IS CURRENTLY REGISTERED UNDER PROCODE BXB AS INDICATED IN (D2B). THIS DEVICE IS CURRENTLY PENDING 510(K) APPROVAL UNDER PROCODE PHL. EVALUATION RESULTS AND CONCLUSION: AS ROOT CAUSE ANALYSIS IS STILL PENDING EVALUATION. REMEDIAL ACTION: ROOT CAUSE ANALYSIS IS STILL PENDING EVALUATION.

    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 #3 SIMILAR TO MDR 30009495988-2015-00001]. CUSTOMER REPORTED THAT THE MALFUNCTION OCCURRED WHILE WALKING IN A STRAIGHT LINE ON A LEVEL SURFACE IN THEIR CLINIC HALLWAY. NO ISSUES/SOUNDS COMING FROM DEVICE PRIOR OF MALFUNCTION. DURING LEFT FOOT INITIAL SWING, OR MID SWING, THEY HEARD A LOUD POP AND IMMEDIATELY PLACE THE DEVICE IN A SAFE STAND STILL MODE AS TRAINED. CUSTOMER NOTICED THAT THE LEFT FOOT PLATE HAD COME SEPARATED FROM THE DEVICE. PHYSICAL THERAPIST WAS SPOTTING AND ABLE TO KEEP PT STEADY, WHILE PERSON ON THE REMOTE ALWAYS KEEPS HIS FINGER OVER THE STAND STILL BUTTON ANYWAY, HE REPORTED, SO THEY WERE ABLE TO VERY QUICKLY AND SAFELY NAVIGATE. PT WAS IMMEDIATELY LOWERED 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 46 YR