BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FLUTED BUR

    MDR report key: 2476069 · Received February 22, 2012

    Report

    Report Number
    9616696-2012-00039
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 27, 2012
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBJECT TO THIS INVESTIGATION HAS NOT BEEN RETURNED YET TO THE MFR FOR EVAL. THE MFG HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE LABEL FOR THIS DEVICE HAS A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED". THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF A DEVICE. IT WAS ALSO REPORTED THAT THESE DEVICES WERE NOT USED ON A PT AND THE BREACH WAS NOTICED OUTSIDE OF THE STERILE AREA. IT WAS FURTHER REPORTED THAT THERE WAS NO DELAYS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND FLUTED BUR EQJ STRYKER IRELAND LTD. 11314017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK