BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    #2.0 DRILL BIT

    MDR report key: 865487 · Received June 12, 2007

    Report

    Report Number
    MW5002626
    Event Type
    Malfunction
    Date Received
    June 12, 2007
    Date of Event
    May 26, 2006
    Report Date
    June 12, 2007
    Manufacturer
    NA
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    #2.0 DRILL BIT BROKE IN HALF DURING THE DRILLING OF THE MOST INFERIOR ASPECT LOCKING SCREW. THE BROKEN PIECE REMAINED IN THE INFERIOR SCAPULA. DATES OF USE: ONE DAY IN 2006. EVENT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 #2.0 DRILL BIT HTT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR