BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_INSTRUMENTSTIRE_PRODUCT

    MDR report key: 3831641 · Received May 26, 2014

    Report

    Report Number
    0001811755-2014-01922
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED. THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND TO BE STUCK INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER, A BROKEN BUR WAS FOUND TO BE STUCK INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309926 UNKNOWN_INSTRUMENTSTIRE_PRODUCT UNKNOWN GFA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) LOT 10245| (B)(4) LOT 10245