BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB MICRO DRILL

    MDR report key: 3133461 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01222
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, HANDPIECE RUN-ON, WAS NOT DUPLICATED; IT WAS CONFIRMED THAT THE DEVICE HAD A CORROSION BY THE SERVICE TECHNICIAN THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY AND VISUAL INSPECTION. UPON DISASSEMBLY, THE MOTOR WAS FOUND CORRODED. THE PRESENCE OF A MOTOR CORROSION IS LIKELY TO CAUSE OR CONTRIBUTE TO RUN-ON.

    Description of Event or Problem · 1

    THE REMB MICRO DRILL WAS SENT FOR EVALUATION DUE TO RUNNING ON ITS OWN AFTER USE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236404 REMB MICRO DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1