BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL BLADE

    MDR report key: 1942027 · Received November 11, 2010

    Report

    Report Number
    9616696-2010-00331
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES SUBJECT TO THIS INVESTIGATION WERE NOT RETURNED FOR EVAL. THE MFG HISTORY RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. IT WAS VISUALLY CONFIRMED FROM PHOTOGRAPHS 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 WHILE SETTING UP FOR SURGERY, IT WAS NOTED THAT THE PACKAGING ON 2 BLADES WAS DAMAGED. 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 ANOTHER BLADE 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 HWE STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK