BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2851386 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03916
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED DURING FAILURE ANALYSIS THAT THERE WERE NO PROBLEMS FOUND WITH THE DEVICE. OVERHEATING WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    THE CORDLESS DRIVER WAS SENT FOR EVALUATION DUE TO OVERHEATING DURING TESTING. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK