BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBRATED DRILL BIT Ø3.1MM X 285MM, AO

    MDR report key: 3131671 · Received May 29, 2013

    Report

    Report Number
    0008031020-2013-00165
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.1 MM CALIBRATED DRILL BIT WAS DRILLED INTO A TOTAL KNEE AND BROKE INSIDE THE PATIENT. THE BROKEN PIECE OF THE DRILL BIT REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237383 CALIBRATED DRILL BIT Ø3.1MM X 285MM, AO INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other