BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-CUT FISSURE BUR, TAPERED

    MDR report key: 2211649 · Received August 5, 2011

    Report

    Report Number
    9616696-2011-00131
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 11, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREE BURS SUBJECT TO THIS INVESTIGATION WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THREE BURS BROKE. IT WAS ALSO REPORTED THAT THERE WAS NO KNOWN DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS-CUT FISSURE BUR, TAPERED EQJ STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK