BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT BLADE

    MDR report key: 2171068 · Received June 29, 2011

    Report

    Report Number
    9616696-2011-00106
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TEN BLADES AND PACKAGING SUBJECT TO THIS INVESTIGATION WERE RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE PACKAGING MATERIAL WAS BRITTLE FOR FIVE OF THE RETURNED BLADE PACKAGES. THE LABEL FOR THIS 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 WHILE PREPARING FOR SURGERY, IT WAS NOTED THAT THE PACKAGING OF THREE BLADES WOULD NOT PEEL OPEN AS SPECIFIED. IT WAS ALSO REPORTED THAT THE BLADES WERE NOT USED ON A PT AND THE STERILE AREA WAS NOT COMPROMISED. IT WAS FURTHER REPORTED THAT BACK UP BLADES WERE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT BLADE GFA STRYKER IRELAND LTD. 07065017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK