BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CUT SAGITTAL BLADE

    MDR report key: 2093062 · Received April 15, 2011

    Report

    Report Number
    9616696-2011-00056
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS INVESTIGATION WAS RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT ONE OF THE BLADE TEETH WAS BROKEN FROM THE BLADE. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE TOOTH BROKE FROM THE CUTTING END OF THE BLADE, IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL CUT SAGITTAL BLADE GFA STRYKER IRELAND LTD. 10306017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK