BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3009495988-2015-00001

    MDR report key: 5021117 · Received August 6, 2015

    Report

    Report Number
    3009495988-2015-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 5, 2015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED ITEMS WERE RETURNED TO MANUFACTURER ((B)(4)) FOR EVALUATION. MANUFACTURE DETERMINED THAT FASTENERS SHEARED UNDER BENDING STRESSES GREATER THAN THE FATIGUE LOAD OF THE FASTENER CAUSING THE FOOT PLATE TO SEPARATE FROM THE ANKLE. SOME EVIDENCE OF DAMAGE WAS IDENTIFIED WHICH MAY BE INDICATIVE OF MISUSE OR DEVICE HANDLING ISSUE. FAILURE MODE OF FASTENERS WAS FROM BENDING FATIGUE, HOWEVER ROOT CAUSE ANALYSIS OF FAILURE MODE IS STILL UNDER INVESTIGATION AND AFFECTED ITEMS HAVE BEEN RETAINED. THIS DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. ADDITIONAL INFORMATION FOLLOW-UP WILL BE SUBMITTED WHEN THE FOLLOWING INFORMATION BECOMES AVAILABLE. (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.

    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. LOW RISK FAILURE DUE TO SAFEGUARDS IN PLACE ELIMINATING ANY REALISTIC POSSIBILITY OF PATIENT HARM. DESIGN IMPROVEMENTS WERE IDENTIFIED, WHICH FURTHER INCREASE THE DURABILITY OF THE DEVICE. IMPROVEMENTS TO BE IMPLEMENTED AT THE NEXT ROUTINE SERVICE PERIOD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING USE THE LEFT FOOT PLATE BECAME SEPARATED FROM THE REST OF THE ANKLE ON THE DEVICE. PATIENT WAS SAFELY REMOVED FROM THE DEVICE ANS SUSTAINED NO INJURY. NO PHYSICAL THERAPISTS, OR THIRD PERSONS HAVE BEEN AFFECTED OR INJURED.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR