BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC SCREW DRIVER F/SELF-LOCKING SCREWS

    MDR report key: 4231797 · Received October 15, 2014

    Report

    Report Number
    3005673311-2014-00070
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    February 13, 2014
    Report Date
    September 2, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVAL: SCREWDRIVER WAS DISCARDED BY END USER. LOT NUMBER WAS NOT PROVIDED. TREND ANALYSIS INDICATES THERE HAVE BEEN NO ADVERSE EVENTS THAT HAVE GENERATED REMEDIAL ACTION.

    Description of Event or Problem · 1

    SURGEON STATES HE DRILLED TO 14MM DEPTH, AND INSERTED A 14MM SCREW (FJ932T/LOT NO. UNK). SCREWDRIVER (FJ910R) TIP SHEARED OFF INTO ONE OF THE SCREWHEAD. SURGEON WAS UNABLE TO RETRIEVE THE TIP. SECOND SCREW WAS STRIPPED. SURGEON FELT THE SCREWS WERE SEATED WELL ENOUGH. SURGEON THEN INSERTED 6 ADD'L SCREWS INTO THE PLATE WITH THE BACK UP SCREWDRIVER. SURGEON CHOOSE TO CLOSE THE PT AND LEAVE THE SCREWS IN THE PLATE. SURGERY WAS COMPLETED AS EXPECTED. SURGERY WAS DELAYED APPROXIMATELY 30-45 MINS. F/U REPORTS FOR PT INDICATE PT IS HEALING WELL. COMPONENTS INVOLVED: (TWO) FJ932T / ABC SELF-LOCKING CERVICAL SCREW 4.0X14MM LOT/BATCH NUMBERS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652687 ABC SCREW DRIVER F/SELF-LOCKING SCREWS SCREW DRIVER HXX AESCULAP AG & CO. KG FJ910R

    Patients

    Seq Age Sex Outcome Treatment
    1