BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET

    MDR report key: 6063248 · Received October 26, 2016

    Report

    Report Number
    MW5065660
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE ARTHRODESIS PORTION OF THIS PROCEDURE, THE ARTHRODESIS SITES WERE BEING FURTHER STABILIZED WITH TWO L PLATES SECURED BY LOCKING SCREWS SPANNING THE 2ND AND 3RD TARSAL-METATARSAL JOINT. THE LOCKING PLATES HAD BEEN PLACED ACROSS THE ARTHRODESIS SITE WITH STANDARD AO TECHNIQUE. WHEN PUTTING IN TWO OF THE SCREWS, THE TIP OF THE DRIVER BROKE OFF INSIDE THE SCREW HEAD 1.3 SQUARE DRIVER CAT #2312-18-012 FROM THE ZIMMER BIOMET A.L.P.S. FOOT SET 2.5 SCREW CADDY. UNABLE TO RETRIEVE THE TIP FROM THE SCREW HEADS AND LEFT INTACT. VENDOR WAS PRESENT AT THE PROCEDURE AND TOOK POSSESSION OF THE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709776 ZIMMER BIOMET 1.3 SQUARE DRIVER HXX ZIMMER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR