BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT

    MDR report key: 3951715 · Received July 23, 2014

    Report

    Report Number
    0001811755-2014-02612
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT FOR HEAT WAS CONFIRMED BY THE QA TECHNICIAN THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY AND VISUAL INSPECTION. CORROSION WAS FOUND INSIDE THE DEVICE. THE ATTACHMENT IS NOT A REPAIRABLE DEVICE AND WILL NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430242 CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1