BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB UNIVERSAL DRIVER

    MDR report key: 2241684 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03208
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZI
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE DEVICE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THIS RECORD WILL BE UPDATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE WOULD OPERATE WITHOUT ACTIVATION BY THE USER. THIS OCCURRED DURING A BUNIONECTOMY. A BACK UP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMB UNIVERSAL DRIVER DZI STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK