BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIVERSAL DRIVER

    MDR report key: 2070821 · Received April 15, 2011

    Report

    Report Number
    1811755-2011-01283
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K942956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE RUNNING ON ITS OWN WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS CORROSION AND PROBLEMS WITH THE POTTED TRIGGER ASSEMBLY, DRIVESHAFT, BEARINGS, AND THE FLEX IN THE MOTOR ASSEMBLY. THOSE PARTS WERE EACH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRIVER CONTINUED TO RUN ON ITS OWN DURING A SMALL BONE FRACTURE REPAIR PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO MEDICAL INTERVENTION. 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 UNIVERSAL DRIVER HWE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK