BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS SYNOVATOR

    MDR report key: 1973757 · Received January 17, 2011

    Report

    Report Number
    1973757
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 17, 2011
    Manufacturer
    SMITH AND NEPHEW ENDOSCOPY, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT WAS TAKEN TO SURGERY FOR KNEE ARTHROSCOPY AND MENISCECTOMY. WHILE USING THE SMITH AND NEPHEW CURVED SYNOVATOR BLADE THE SURGEON ENCOUNTERED A PROBLEM IN THAT THE SHAVER WAS "BINDING UP" AND NOT ROTATING FREELY (THIS INSTRUMENT SHOULD SPIN FREELY ALLOWING THE SURGEON TO SHAVE BONE AS NEEDED IN ORTHOPEDIC SURGICAL CASES). ONCE THIS PROBLEM WAS ENCOUNTERED THE SURGEON STOPPED USING THE SYNOVATOR AND UTILIZED ANOTHER DEVICE TO COMPLETE THE CASE. THE PROCEDURE WAS FINISHED AND THE PATIENT WAS SENT TO THE PACU FOR RECOVERY. THE DEVICE WAS RETAINED FOR RISK MANAGEMENT. THERE WAS NO INJURY TO THE PATIENT.======================MANUFACTURER RESPONSE FOR DYONICS 4.5MM CURVED SYNOVATOR CONCAVE ARTHROSCOPIC SHAVER, DYONICS======================WE HAVE ENCOUNTERED A PREVIOUS ISSUE OF THIS TYPE WITH THIS PARTICULAR DEVICE. WE HAVE RETURNED 13 TO THE MANUFACTURER FOR EVALUATION, 3 OF WHICH FAILED DURING USE. TEN DEVICES OF THE 13 WERE UNUSED FROM THE SAME LOT NUMBER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR