BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-CUT FISSURE BUR, LONG ROUND END TAPERED"

    MDR report key: 4188440 · Received October 21, 2014

    Report

    Report Number
    0001811755-2014-03690
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EJL
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR AND HANDPIECE DRILL (5400300000 SN (B)(4)) SUBJECT TO THIS INVESTIGATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BUR WAS BROKEN ALONG THE SHANK. NO FURTHER DEVICE INSPECTION WAS POSSIBLE AS THE BUR COULD NOT BE REMOVED FROM THE ATTACHMENT. BASED ON REVIEW OF THE INFORMATION PROVIDED IN RELATION TO THIS REPORTED EVENT AND AS DEVICE INSPECTION OF THE AFFECTED PRODUCT IS NOT POSSIBLE, THE ROOT CAUSE OF THIS EVENT IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING THE BUR BROKE IN HALF, HALF OF THE BUR REMAINED STUCK IN THE DRILL AND THE OTHER HALF BECAME EMBEDDED IN THE WALL. THERE WAS NO ASSOCIATED PROCEDURE AND NO PATIENT IMPACT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING THE BUR BROKE IN HALF, HALF OF THE BUR REMAINED STUCK IN THE DRILL AND THE OTHER HALF BECAME EMBEDDED IN THE WALL. THERE WAS NO ASSOCIATED PROCEDURE AND NO PATIENT IMPACT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668148 CROSS-CUT FISSURE BUR, LONG ROUND END TAPERED" BUR, DENTAL EJL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BUR GUARD| 5400300000 SN (B)(4)| 5400300000 LOT (B)(4)