BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BUR

    MDR report key: 2093064 · Received April 15, 2011

    Report

    Report Number
    9616696-2011-00057
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR AND HANDPIECE SUBJECT TO THIS MDR WAS RETURNED FOR INVESTIGATION. IT WAS VISUALLY CONFIRMED THAT THE BUR WAS STUCK IN THE HANDPIECE AND WAS BROKEN ALONG THE SHANK OF THE BUR. PART AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED. D4: THE HANDPIECE ASSOCIATED WITH THIS MDR IS AS FOLLOWS: PART NUMBER: 5400300000, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCE AND ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER REPORTED THAT THIS EVENT DID NOT RESULT IN A DELAY TO SURGERY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BUR EQJ STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK