BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.3MM DRILL 25MM

    MDR report key: 2091367 · Received May 5, 2011

    Report

    Report Number
    2249697-2011-00661
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON WAS DRILLING A HOLE THROUGH THE ACETABULAR CUP PRIOR TO IMPLANTING A SCREW AND THE DRILL BIT BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.3MM DRILL 25MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention