BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 3802601 · Received May 9, 2014

    Report

    Report Number
    0001811755-2014-01686
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K943540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT CONFIRMED DURING THE DEVICE EVALUATION AND NO OTHER FAILURES WERE DETECTED. THE DEVICE WAS DISCARDED BY THE MANUFACTURER. IT WAS CONFIRMED THAT THE HANDPIECE (CORE IMPACTION DRILL 5400300000 ((B)(4))), WHICH IS LISTED HAD FAILURES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, AS THERE ARE NO HALL SENSORS IN THIS HANDPIECE, A BIAS-CURRENT WARNING SERVES NO PREVENTATIVE PURPOSE IN TERMS OF RUN-ON; THEREFORE, A REPORT WILL NOT BE FILED ON THE HANDPIECE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP AT THE USER FACILITY THE TPS HANDPIECE CORD CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP AT THE USER FACILITY THE TPS HANDPIECE CORD CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281914 TPS HANDPIECE CORD DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO 13070

    Patients

    Seq Age Sex Outcome Treatment
    1 CORE CONSOLE 5400050000 ((B)(4))| CORE IMPACTION DRILL 5400300000 ((B)(4))