BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS MICRO DRIVER

    MDR report key: 4221782 · Received November 3, 2014

    Report

    Report Number
    0001811755-2014-03932
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K943540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT THE DEVICE WAS RUNNING IN SAFE MODE, AND NOTED A DAMAGED PCB. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REPAIR THE TPS MICRO DRIVER WAS FOUND TO BE RUNNING IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING REPAIR, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703803 TPS MICRO DRIVER BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1