BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM COARSE DIAMOND ROUND, 16CM

    MDR report key: 12853495 · Received November 22, 2021

    Report

    Report Number
    3015967359-2021-02608
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 27, 2021
    Report Date
    February 25, 2022
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HBE
    UDI-DI
    07613327096941
    PMA / PMN Number
    K143540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE LOT NUMBER REPORTED INITIALLY WAS 1926017, THE CORRECTED LOT NUMBER IS 19262017.

    Additional Manufacturer Narrative · 0

    H6: THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE CUSTOMER THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS A TEN MINUTE DELAY AS A RESULT OF THIS EVENT. 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 VIA THE CUSTOMER THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS A TEN MINUTE DELAY AS A RESULT OF THIS EVENT. 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 VIA THE CUSTOMER THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT THERE WAS A TEN MINUTE DELAY AS A RESULT OF THIS EVENT. 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
    1748988 4.0MM COARSE DIAMOND ROUND, 16CM DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 8470012040DC 19262017 07613327096941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown