BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 2160681 · Received June 30, 2011

    Report

    Report Number
    1811755-2011-02313
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE WAS DEBRIS BUILT UP INSIDE THE DEVICE. THIS CONDITION COULD CAUSE THE DEVICE TO NOT RETAIN THE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A WIRE DURING A PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK UP DEVICE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE COLLET GET STRYKER INSTRUMENTS KALAMAZOO 11005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK