BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIVERSAL DRIVER

    MDR report key: 2903154 · Received November 26, 2012

    Report

    Report Number
    1811755-2012-04167
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL THIRD PARTY PARTS WERE FOUND DURING DEVICE EVAL, INCLUDING THE MOTOR ASSEMBLY AND THE POTTED TRIGGER, WHICH ARE PROBABLE CAUSES OF THE DEVICE RUNNING WITHOUT USER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MFR FACILITY, THE DEVICE WAS RUNNING AT LOW SPEED WITHOUT USER ACTIVATION. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS UNIVERSAL DRIVER ERL STRYKER INSTRUMENTS, INSTRUMENTS DIV.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK