BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, AO 4,2X340 MM

    MDR report key: 2091365 · Received May 5, 2011

    Report

    Report Number
    9610622-2011-00212
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, DRILL BIT BROKE WHILE DRILLING FOR THE PROXIMAL SCREWION A TIBIA NAIL. DRILL BROKE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL, AO 4,2X340 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K942373

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other