BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY HAND INNOVATIONS

    MDR report key: 1033385 · Received April 23, 2008

    Report

    Report Number
    MW5006364
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 23, 2008
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTICED DURING CLOSING AND DRESSING APPLICATION ON PT THAT THE TIP OF THE DRILL BIT HAD BROKEN OFF. A 2.8MM DEPUY DRILL BIT BROKE OFF IN THE PROXIMAL HUMERUS. SURGEON AWARE AND UNABLE TO RETRIEVE THE BROKEN BIT FROM THE PT. DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY HAND INNOVATIONS DEPUY PROXIMAL HUMERUS TRA HRS DB 2.8MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other