BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING AND SAGITTAL BLADE

    MDR report key: 1922095 · Received November 16, 2010

    Report

    Report Number
    9616696-2010-00337
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE AND THE BROKEN PIECE OF THE BLADE SUBJECT TO THIS MDR WERE RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT ONE SECTION OF THE MOUNT OF THE BLADE WAS BROKEN. 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 DURING AN ACL RECONSTRUCTION, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THE BROKEN PIECE DID NOT FALL INTO THE SURGICAL SITE. IT WAS FURTHER REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSCILLATING AND SAGITTAL BLADE SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. 10200017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK