BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE COLLET

    MDR report key: 2140429 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02217
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER INSTRUMENT KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 ROUTINE MAINTENANCE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE COLLET GET STRYKER INSTRUMENT KALAMAZOO 09272

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK