BEUDAMED
    FDA Adverse Event Summary report: N

    MICRO-AIRE DRILL BIT

    MDR report key: 1052028 · Received May 15, 2008

    Report

    Report Number
    1052028
    Date Received
    May 15, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HTW
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A HIP SURGERY PROCEDURE, NURSE NOTED A SMALL PIECE OF THE DRILL BIT BROKE OFF IN THE PATIENT'S FEMUR. SURGEON WAS UNABLE TO RETRIEVE IT. X-RAY CONFIRMS THE FRAGMENT IS IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-AIRE DRILL BIT DRILL BIT, ORTHOPEDIC HTW MICROAIRE SURGICAL INSTRUMENTS, LLC NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR