BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE

    MDR report key: 2152273 · Received June 22, 2011

    Report

    Report Number
    9616696-2011-00101
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PACKAGING SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED FOR EVALUATION. 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 ALTERNATIVE PACKAGING MATERIAL HAS SINCE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP FOR A SURGICAL PROCEDURE, IT WAS NOTED THAT A PORTION OF THE PACKAGING HAD RIPPED OFF. AS A RESULT OF THIS, THE CUSTOMER WAS UNABLE TO OPEN THE PACKAGE. IT WAS ALSO REPORTED THAT THE BLADE WAS NOT USED ON A PT. IT WAS FURTHER REPORTED THAT THE DELAY WAS MINIMAL AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE GFA STRYKER IRELAND LTD. 08213017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK