BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 1823507 · Received August 27, 2010

    Report

    Report Number
    MW5017265
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 27, 2010
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING STRYKER DRILL THE 3.0MM DRILL BIT BROKE OFF. THE END PIECE WAS FOUND AND REMOVED. DIAGNOSIS OR REASON FOR USE: ORTHO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS STRYKER 3.0MMX3.8MM PRECISION NEURO DRILL HTW 5820-107-530

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability