BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TAPERED ROUTER

    MDR report key: 7024883 · Received November 13, 2017

    Report

    Report Number
    0001811755-2017-02351
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 22, 2017
    Report Date
    December 26, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    7613327096736
    PMA / PMN Number
    K143399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS INDICATES THE DEVICE CAME INTO CONTACT WITH A HARDENED MATERIAL OR METAL THAT WOULD CAUSE THE ROUNDING ON THE FLUTE EDGE CAUSING THE FRACTURE. THE IFU FOR THE ATTACHMENT (5407-210-768 REV-B) HAS THE FOLLOWING WARNING;"DO NOT APPLY EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, WITH THE CUTTING ACCESSORY, FOOT, OR LEG. EXCESSIVE PRESSURE MAY FRACTURE THE CUTTING ACCESSORY OR BEND THE ATTACHMENT FOOT OR LEG."" DO NOT LET THE SPINNING CUTTING ACCESSORY COME INTO CONTACT WITH RETRACTORS OR OTHER METAL TOOLS. METAL SHAVINGS COULD DETACH FROM THE EQUIPMENT AND FALL INTO THE SURGICAL SITE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE ROUTER BROKE AT THE TIP. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE ROUTER BROKE AT THE TIP. IT WAS ALSO REPORTED 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
    805242 3.0MM TAPERED ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN 7613327096736

    Patients

    Seq Age Sex Outcome Treatment
    1