BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3173250 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01405
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE MOTOR ASSEMBLY AND WEAR WAS FOUND ON THE SPINDLE HOUSING AND THE ROTOR COUPLER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE CORE IMPACTION DRILL HAD AN OVER TEMPERATURE WARNING ON THE CONSOLE. WHILE TESTING THE DEVICE AT THE MANUFACTURER IT WAS REPORTED THAT THE DEVICE HEATED UP. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272939 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1