BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBRATED DRILL BIT 3.1MM X 285MM, AO

    MDR report key: 2112203 · Received April 29, 2011

    Report

    Report Number
    8031020-2011-00089
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 12, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON WAS DRILLING THE HOME RUN SCREW ON A TIBIAL PLATEAU FRACTURE. HE THREADED THE CANNULA IN THE PLATE FOR THE HOME RUN SCREW AND THE DRILL BEGAN MAKING A STRANGE CHATTER. THE REP COMMENTED ON THE NOISE FROM THE DEVICE. THE SURGEON BACKED THE DRILL OUT THINKING IT MIGHT BE CORTICAL CHATTER BECAUSE IT WAS A YOUNG PATIENT. HE PROCEEDED TO DRILL THE HOLE AND THE DRILL TIP BROKE OFF. A NEW DRILL WAS USED AND THE EVENT HAPPENED AGAIN. THEY TOOK A LATERAL VIEW OF THE BROKEN TIPS IN THE PATIENT AND THE REP NOTED THAT THEY WERE BUTTED FIRMLY AGAINST THE POSTERIOR CORTICAL BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALIBRATED DRILL BIT 3.1MM X 285MM, AO INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA K539245

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other