BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERE90 ELECTRODE

    MDR report key: 6119179 · Received November 21, 2016

    Report

    Report Number
    1221934-2016-10498
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION UNDER MAGNIFICATION REVEALED THAT A SMALL PORTION OF THE WHITE CERAMIC SURROUNDING THE ACTIVE TIP WAS CHIPPED OFF. THE DAMAGE TO THE DISTAL TIP IS LIKELY TO BE CAUSED BY THE INTRODUCTION OF ANOTHER METAL INSTRUMENT DURING THE PROCEDURE. THE IFU STATES: ¿OBSERVE EXTREME CAUTION WHEN USING ELECTRO SURGERY IN CLOSE PROXIMITY TO OR IN DIRECT CONTACT WITH ANY METAL OBJECTS. THE MAJORITY OF ARTHROSCOPES AND ARTHROSCOPIC INSTRUMENTS ARE METAL. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE.¿ THE ELECTRODE WAS NOT TESTED TO AVOID FURTHER DAMAGE TO THE TIP. HISTORICALLY, THIS TYPE OF FAILURE IS ATTRIBUTED TO A USER ERROR. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED 1 DISSIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WAS RELEASED TO DISTRIBUTION. AT THIS POINT, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    THE HEAD OF THE ELECTRODE BROKE INSIDE THE KNEE OF THE PATIENT. THE BROKEN PART FELL INTO THE PATIENT'S KNEE AND WAS RETRIEVED THANKS TO AN ARTHROSCOPY CLAMP. USE OF ANOTHER ELECTRODE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS LENGTHENED OF 10 MINUTES. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION 10-25-2016: THE ELECTRODE WAS NEW, NOT REPROCESSED.

    Description of Event or Problem · 1

    THE HEAD OF THE ELECTRODE BROKE INSIDE THE KNEE OF THE PATIENT. THE BROKEN PART FELL INTO THE PATIENT'S KNEE AND WAS RETRIEVED THANKS TO AN ARTHROSCOPY CLAMP. USE OF ANOTHER ELECTRODE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS LENGTHENED OF 10 MINUTES. NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767950 PREMIERE90 ELECTRODE VAPR ELECTRODES GEI DEPUY MITEK U1606152

    Patients

    Seq Age Sex Outcome Treatment
    1