BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS MICRO DRIVER

    MDR report key: 2121123 · Received May 4, 2011

    Report

    Report Number
    1811755-2011-01595
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K942956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. DURING THE INVESTIGATION, THE DEVICE RAN IN SAFE MODE. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE MOTOR, WHICH WAS REPLACED ALONG WITH THE DRIVESHAFT, ROTOR, BEARINGS, AND OTHER COMPONENTS. SERVICE REPAIRED THE DRIVER.

    Description of Event or Problem · 1

    THE DRIVER WAS RETURNED TO THE MANUFACTURER AS A TRADE-IN, AND DURING THE INVESTIGATION, THE DEVICE RAN IN SAFE MODE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS MICRO DRIVER HWE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK