BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND NEURO BUR, ELITE

    MDR report key: 1934660 · Received November 26, 2010

    Report

    Report Number
    9616696-2010-00350
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE PACKAGING WAS PUNCTURED AT THE NOTCH END OF THE BUR. THE MANUFACTURING HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE LABEL FOR THIS DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED." THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR WAS STICKING THROUGH THE STERILE PACKAGING. IT WAS ALSO REPORTED THAT THIS WAS NOTICED BY THE USER WHEN THE BOX WAS OPENED AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND NEURO BUR, ELITE DRILLS, BURS, TREPHINES & ACCESSORIES GFF STRYKER IRELAND LTD. 10271027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK