BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR TPS MICRO DRILL

    MDR report key: 1621385 · Received February 17, 2010

    Report

    Report Number
    1811755-2010-00157
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 20, 2010
    Report Date
    January 20, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVAL, BUT THE REPORTED CONDITION OF THE DEVICE OVERHEATING DURING USAGE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING AN ORTHOPAEDIC SURGICAL PROCEDURE. THERE WAS NO REPORTED PT OR USER INJURY, AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR TPS MICRO DRILL SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK