BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 2132290 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02117
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    March 28, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE EVENT WAS CONFIRMED. THERE WAS CORROSION DAMAGE ON THE MOTOR, ROTOR ASSEMBLY, AND BEARINGS. THE MOTOR WAS FOUND TO HAVE SEIZED DUE TO THE CORROSION DAMAGE TO THE ROTOR ASSEMBLY, BEARINGS AND ATTACHMENT LOCK. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. THERE WERE NO RELEVANT NON-CONFORMANCES, ALERTS, DEVIATIONS, OR REWORK RELATED TO THIS CONFIRMED FAILURE. THERE WERE NO RELEVANT DESIGN/PROCESS CHANGES RELATED TO THIS CONFIRMED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS RUNNING AT HIGH TEMPERATURES. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HIGH TORQUE DRILL HBE STRYKER INSTRUMENTS KALAMAZOO 0523500683

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK