BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2896550 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04131
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 3, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE OVERHEATING REPORTED WITHOUT AN EVAL OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MFR FIELD SERVICE TECH AT THE USER FACILITY, THE DEVICE WAS OVERHEATING, INTERMITTENTLY RUNNING FASTER OR SLOWER THAN EXPECTED SPEED AND THE OSCILLATING FORWARD/BACK MOVEMENTS WERE NOT CONSISTENT WITH THE NORMALLY EXPECTED OSCILLATIONS OF THIS 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