BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM X 10.0MM TAPERED ROUTER

    MDR report key: 8905775 · Received August 19, 2019

    Report

    Report Number
    0001811755-2019-02720
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 28, 2019
    Report Date
    October 14, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    UDI-DI
    04546540467690
    PMA / PMN Number
    K143320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS INDICATE THAT HE MOST LIKELY CAUSE OF BREAKAGE WAS LACK OF IRRIGATION COMBINED WITH EXCESSIVE FORCE AND/OR THE APPLICATION OF A BENDING MOMENT DURING USE. A REVIEW OF THE LABEL, #5820-103-702 REVISION AA, THE LABEL INDICATES BY WAY OF AN EXPANDABLE LABEL 0036-902-000 REVISION B ICON "DO NOT USE EXCESSIVE FORCE". THE ASSOCIATED DEVICES IFU FOR USE WAS REVIEWED AND CONTAIN THE FOLLOWING WARNING; "DO NOT APPLY EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, WITH THE CUTTING ACCESSORY. EXCESSIVE PRESSURE MAY BEND OR FRACTURE THE CUTTING ACCESSORY." THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE BUR BROKE. 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 USING A BACK-UP BUR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE BUR BROKE. 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 USING A BACK-UP BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698957 1.5MM X 10.0MM TAPERED ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN 04546540467690

    Patients

    Seq Age Sex Outcome Treatment
    1