BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE

    MDR report key: 2171067 · Received June 29, 2011

    Report

    Report Number
    9616696-2011-00105
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGING AND DEVICE SUBJECT TO THIS INVESTIGATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE PACKAGING HAD BEEN DAMAGED. THE MANUFACTURING 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." INVESTIGATION RESULTS INDICATE THAT THE PACKAGING OF THE DEVICE MAY HAVE BEEN HANDLED AGGRESSIVELY DURING STORAGE OR IN TRANSPORTATION TO THE ACCOUNT, BUT THIS CANNOT BE CONFIRMED. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR A SURGICAL PROCEDURE, IT WAS NOTED THAT THERE WAS A POTENTIAL STERILITY BREACH OF THE PACKAGING FOR THE DEVICE. IT WAS ALSO REPORTED THAT THESE DEVICES WERE NOT USED ON A PT AND THE STERILE AREA WAS NOT COMPROMISED. IT WAS ALSO REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE AND THERE WERE NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THERE WAS NO ADVERSE CONSEQUENCES TO THE PT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE GFA STRYKER IRELAND LTD. 11074017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK