BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB ELECTRIC WIREDRIVER

    MDR report key: 1935142 · Received December 6, 2010

    Report

    Report Number
    1811755-2010-01915
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIREDRIVER CONTINUED TO RUN WHEN THE TRIGGER WAS RELEASED DURING SETUP FOR A PROCEDURE, WHICH HAD NOT BEGUN YET. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER DEVICE WAS USED TO BEGIN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMB ELECTRIC WIREDRIVER SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK