BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.1MM CROSS-CUT FISSURE EXTENDED

    MDR report key: 8152890 · Received December 11, 2018

    Report

    Report Number
    0001811755-2018-02741
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 15, 2018
    Report Date
    February 8, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K143320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER UPDATED FROM UNKNOWN TO 5820066221. INVESTIGATION RESULTS INDICATE THAT THE BUR WAS NOT FITTED TO THE CORRECT ATTACHMENT, THIS IS THE LIKELY CAUSE OF BREAKAGE. A REVIEW OF THE LABEL, #5820-101-700 REVISION A, HAS "UW" (USE WITH) INSTRUCTIONS AS FOLLOWS; "UW 5100-010-4XX, 5100-120-4XX, 5407-120-4XX" THE ATTACHMENT USED WAS CATALOG NUMBER 5100-015-252. THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BUR BROKE WHILE TRYING TO REMOVE IT FROM THE MICRO DRILL ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING DEVICE RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR BROKE WHILE TRYING TO REMOVE IT FROM THE MICRO DRILL ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992328 2.1MM CROSS-CUT FISSURE EXTENDED DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 5100015252, L18052