BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOC(TM) 3DSI CLAW(R) II PLATE

    MDR report key: 4260129 · Received November 18, 2014

    Report

    Report Number
    1043534-2014-00168
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 18, 2014
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    PMA / PMN Number
    K113014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS BEEN RETURNED. TRENDS WILL BE EVALUATED. (B)(4). THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2014-00169.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PARTS FOUND THE REMNANTS OF THE 2-HOLE PLATE, A BROKEN SCREW, AND A SCREW STILL ATTACHED TO A SCREW HOLE. A MICROSCOPIC EXAMINATION WAS CONDUCTED AND IDENTIFIED THE PART AND LOT NUMBERS. VISIBLE SCRATCHES, INDENTATIONS AND TOOL MARKS ARE EVIDENT ON THE RETURNED PIECES. THE BROKEN SCREW WAS VIEWED AS WELL. THE IDENTIFICATION OF THE SCREW COULD NOT BE PERFORMED OTHER THAN THE WIDTH, WHICH WAS 3.5 MM. THE BREAKAGE OCCURRED ON THE SHANK APPROXIMATELY FOUR THREADS DISTAL TO THE HEAD. ANALYSIS OF THE RETURNED DEVICES INDICATES THAT THE DEVICE WAS A CONTRIBUTOR TO THE REPORTED EVENT. BASED ON ANALYSIS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER THE MOST LIKELY ROOT CAUSE WAS DUE TO EXTERNAL STRESSES APPLIED TO THE PLATE AND SCREW; THE SOURCE OF THE STRESS COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    ALLEGEDLY BOTH THE TWO HOLE AND FOUR HOLE PLATES BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746662 ORTHOLOC(TM) 3DSI CLAW(R) II PLATE SMALL JOINT COMPONENT HRS WRIGHT MEDICAL TECHNOLOGY, INC. 1477587

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention