BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS SYNOVATOR

    MDR report key: 1970868 · Received January 14, 2011

    Report

    Report Number
    1970868
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 14, 2011
    Manufacturer
    SMITH AND NEPHEW, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT TAKEN TO SURGERY FOR ARTHROSCOPY OF THE LEFT KNEE WITH PARTIAL LATERAL MENISCECTOMY. UPON USING THE SMITH AND NEPHEW DYONICS ARTHROSCOPIC SURGERY BLADE, IT APPEARED TO START "FLAKING" AT THE SHARP SHAVING POINT, LEAVING METAL SHAVINGS IN THE PATIENT'S JOINT. SURGEON IMMEDIATELY DISCONTINUED USE OF THE SHAVER AND IRRIGATED THE PT'S JOINT WITH COPIOUS AMOUNTS OF SALINE TO FLUSH OUT THE SHAVINGS UNTIL NONE WERE VISIBLE. ANOTHER SHAVER WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER ISSUES WERE NOTED. PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE PACU FOR RECOVERY.====================== MANUFACTURER RESPONSE FOR 4.5MM CURVED SYNOVATOR CONCAVE ARTHROSCOPIC SURGICAL BLADE, DYONICS======================WE HAVE REPORTED THESE ISSUES PREVIOUSLY ON SEVERAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS SYNOVATOR ARTHROSCOPE, BLADE, CONCAVE HRX SMITH AND NEPHEW, INC. 7205334 50530083

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR