BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE INTRA-ORAL BLADE

    MDR report key: 2024198 · Received February 24, 2011

    Report

    Report Number
    9616696-2011-00027
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    STRYKER IRELAND, LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR WAS RETURNED TO THE MFR FOR EVAL. IT WAS VISUALLY CONFIRMED THAT THE DEVICE WAS BROKEN AT THE JOINT BETWEEN THE SHANK AND THE BLADE. THE RETURNED PART WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FACIAL SURGICAL PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT ALL THE BROKEN PIECES WERE RETRIEVED AND THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ANOTHER BLADE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE INTRA-ORAL BLADE SAW BLADES & ACCESSORIES GFA STRYKER IRELAND, LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK