BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 3903162 · Received June 30, 2014

    Report

    Report Number
    0001811755-2014-02328
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K943540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MADE AVAILABLE TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY THE INSULATION AND SHIELD ON THE TPS HANDPIECE CORD WAS FOUND DETACHED AT THE END OF THE CONNECTOR. ATTEMPTS ARE BEING MADE TO RETRIEVE THE PRODUCT FOR EVALUATION AND TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE USER FACILITY. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY THE INSULATION AND SHIELD ON THE TPS HANDPIECE CORD WAS FOUND DETACHED AT THE END OF THE CONNECTOR. ATTEMPTS ARE BEING MADE TO RETRIEVE THE PRODUCT FOR EVALUATION AND TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE USER FACILITY. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380892 TPS HANDPIECE CORD DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1