BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE

    MDR report key: 1900205 · Received October 22, 2010

    Report

    Report Number
    9616696-2010-00310
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 27, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE DEVICES SUBJECT TO THIS INVESTIGATION WERE RETURNED FOR EVAL. THE MANUFACTURING HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. IT WAS VISUALLY CONFIRMED THAT 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 BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP FOR A TOTAL KNEE SURGERY, IT WAS NOTED THAT THE PACKAGING OF 5 BURS WERE POORLY SEALED. IT WAS ALSO REPORTED THAT THE BURS WERE NOT USED ON A PT AND THE STERILE AREA WAS NOT COMPROMISED. IT WAS FURTHER REPORTED ANOTHER BUR WAS READILY AVAILABLE AND THERE WERE NO DELAYS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. 08219017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK