BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND FLUTED BUR, LONG

    MDR report key: 2113854 · Received May 17, 2011

    Report

    Report Number
    9616696-2011-00080
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES SUBJECT TO THIS INVESTIGATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS CONFIRMED THAT THERE WAS A BREACH TO THE STERILE BARRIER FOR TWO OF THE DEVICES. THE MANUFACTURING HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE LABELS OF THESE DEVICES HAVE A SYMBOL INDICATING "STERILE ONLY IF PACKAGE IS UNOPENED AND UNDAMAGED." SUBSEQUENT INVESTIGATION RESULTS INDICATE THAT THE DEVICES WERE HANDLED AGGRESSIVELY DURING STORAGE OR IN TRANSPORTATION TO THE ACCOUNT. CORRECTIVE ACTIONS WERE TAKEN TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND FLUTED BUR, LONG GFF STRYKER INSTRUMENTS CORK 0922 6017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK