BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1464480 · Received August 25, 2009

    Report

    Report Number
    1222081-2009-00028
    Event Type
    Other
    Date Received
    August 25, 2009
    Date of Event
    July 17, 2009
    Report Date
    August 20, 2008
    Manufacturer
    D & R PRODUCTS CO
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BURR HEAD IS BROKEN OFF ON THE DISTAL END WHEN IT ATTACHES TO THE END OF THE SHAFT. THERE IS ONE BROKEN EDGE ON THE BURR HEAD, BUT OTHER THAN THAT THE BURR WAS IN GOOD CONDITION AND CONFORMED TO CORRECT DIMENSIONS. HARDNESS TEST WAS CONDUCTED AND INSTRUMENT FOUND TO BE WITHIN SPECIFICATIONS. IN AN ATTEMPT TO DUPLICATE THE BREAKAGE, A RUN TEST WAS PERFORMED ON A BURR FROM THE SAME BOX WITH THE SAME LOT#. DURING THIS TEST, SIGNIFICANT SIDE LOAD PRESSURE AGAINST ARTIFICIAL BONE WAS APPLIED WITH NO EFFECT. TORQUE TESTING WAS ALSO PERFORMED AND BURR HEAD BROKE OFF AT 13.9 LBS. THE ONLY WAY THE MFR COULD CAUSE THIS KIND OF BREAKAGE WAS BY PLACING TIP OF BURR INTO A HOLE IN THE ARTIFICIAL BONE THAT WAS SLIGHTLY LARGER THAN BURR HEAD AND WHEN LEVER-TYPE DOWNWARD PRESSURE WAS APPLIED, THE BURR HEAD BROKE OFF IN THE SAME LOCATION.

    Description of Event or Problem · 1

    HOSPITAL ALLEGES THAT DOCTOR WAS PERFORMING A SHOULDER ARTHROSCOPY WHEN BURR HEAD BROKE OFF IN PT. DOCTOR LOCATED IT VIA C-ARM AND SWITCHED TO AN OPEN PROCEDURE TO RETRIEVE BURR HEAD. HE THEN COMPLETED PROCEDURE WITH NO OTHER IMPACT ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ DISPOSABLE BURR JXG D & R PRODUCTS CO 28205HDS 31063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other