BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALOR(R) SCREW

    MDR report key: 4944105 · Received July 27, 2015

    Report

    Report Number
    1043534-2015-00052
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 15, 2015
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSB
    PMA / PMN Number
    K090857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT YET BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME REPORT AS 1043534-2015-00051, 1043534-2015-00053, 1043534-2015-00054, 1043534-2015-00055, 1043534-2015-00056.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE SCREW WAS BROKEN INTO TWO SEPARATE PIECES. MIDWAY THROUGH THE SHAFT OF THE SCREW THE THREAD LOOKS TO BE FILED DOWN TO A SMOOTH SURFACE. THE SCREW APPEARS TO HAVE BEEN FORCEFULLY GRINDED AGAINST THE NAIL CAUSING THE SMOOTHNESS OF THE THREAD RESULTING IN THE BREAKING OF THE SCREW. THE PROXIMAL END OF THE THREAD JUST UNDER THE HEAD OF THE SCREW APPEARS TO HAVE ROUGH EDGES THAT ARE FRAYED AND ROUGH DUE TO WEAR AND TEAR. ANALYSIS OF THE RETURNED DEVICE INDICATES THAT THE DEVICE COULD HAVE BEEN A CONTRIBUTOR TO THE REPORT EVENT. THE DEVICE IS BROKEN. BASED ON ANALYSIS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER THE MOST LIKELY ROOT CAUSE MAY HAVE BEEN USER TECHNIQUE DUE TO EXTERNAL FORCE OR STRESS.

    Description of Event or Problem · 1

    ALLEGEDLY, THE NAIL AND SCREWS BROKE BETWEEN THE CALCANEAL AND SUB-TALAR SCREW. REPORTER CAN NOT PREDICT THE DATE OF INCIDENT AND DATE OF ORIGINAL SURGERY BECAUSE THEY WERE PERFORMED IN ANOTHER LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485849 VALOR(R) SCREW SMALL JOINT COMPONENT HSB WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention