BEUDAMED
    FDA Adverse Event Summary report: N

    ZIMMER

    MDR report key: 2982623 · Received February 21, 2013

    Report

    Report Number
    MW5029131
    Date Received
    February 21, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 20, 2013
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT BROKE AND WAS EMBEDDED IN THE PATELLA. THE STAINLESS STEEL DRILL BIT HAD BEEN STERILIZED AND REPACKAGED BY (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77042 ZIMMER DRILL BIT HTW UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other