BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISSURE CARBIDE BUR, TAPERED

    MDR report key: 2926455 · Received January 15, 2013

    Report

    Report Number
    9616696-2013-90010
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER IRELAND LTD
    Product Code
    EJL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE SERIALIZATION STARTING WITH 9616696-2013-90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS. THE DEVICE PACKAGING SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED FOR EVAL. INVESTIGATION RESULTS INDICATE THE PACKAGING MATERIAL WAS BRITTLE. THE LABEL FOR THE DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED." AN ALTERNATE PACKAGING MATERIAL HAS SINCE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE PACKAGING OF THE BUR WOULD NOT PEEL OPEN AS SPECIFIED. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED ANOTHER BUR WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22289 FISSURE CARBIDE BUR, TAPERED EJL STRYKER IRELAND LTD 08031017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK