BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM TAPERED ROUTER

    MDR report key: 15362013 · Received September 6, 2022

    Report

    Report Number
    3015967359-2022-01741
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 19, 2022
    Report Date
    November 17, 2022
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HBE
    UDI-DI
    07613327096729
    PMA / PMN Number
    K143399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE ROUTER BROKE AND THE ROUTER FRAGMENT WAS STUCK IN THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THE BROKEN FRAGMENT WAS SUCCESSFULLY REMOVED WITH THE AID OF O-ARM AND C-ARM SCANS RESULTING IN A TWO HOUR DELAY TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE, THE ROUTER BROKE AND THE ROUTER FRAGMENT WAS STUCK IN THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THE BROKEN FRAGMENT WAS SUCCESSFULLY REMOVED WITH THE AID OF O-ARM AND C-ARM SCANS RESULTING IN A TWO HOUR DELAY TO THE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560714 2.3MM TAPERED ROUTER DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 5407FA2023 22129017 07613327096729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention