BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI SELF-RETAINING CANNULA

    MDR report key: 1910953 · Received November 23, 2010

    Report

    Report Number
    1526605-2010-00002
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 25, 2010
    Manufacturer
    FRANTZ MEDICAL DEVELOPMENT, LTD.
    Product Code
    NBH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EVALUATION OF THE RETURNED DEVICE CONFIRMED THE WING AT THE DISTAL END OF THE CANNULA BROKE OFF DUE TO AN EXCESSIVE AXIAL LOAD. AXIAL LOAD TEST AND INVESTIGATION RESULTS FROM CANNULAS REPRESENTATIVE OF THE LOT CONFIRMED ACCEPTANCE TO THE PRODUCT SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED AND EVALUATION OF THE RETURNED DEVICE, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS NOT DEPLOYING THE CANNULA ACCORDING TO THE INSTRUCTIONS. SPECIFICALLY, IT WAS IMPROPER PLACEMENT OF THE CANNULA IN THE SURGICAL SITE AND THE USE OF EXCESSIVE FORCE. GEMINI SELF-RETAINING CANNULA, INSTRUCTION FOR USE, WARNINGS AND PRECAUTIONS: APPLYING UNDO FORCE TO THE CANNULA ASSEMBLY AND/OR OBTURATOR DURING A PROCEDURE MAY DAMAGE THE PRODUCT AND/OR HARM THE PATIENT. WING DEPLOYMENT AND INNER CANNULA TELESCOPING SHOULD NOT REQUIRE EXCESSIVE FORCE.

    Description of Event or Problem · 1

    SURGEON PERFORMING ARTHROSCOPIC LABRAL REPAIR AND WAS USING GEMINI SR8 SELF RETAINING CANNULA SYSTEM. CANNULA HAS TWO SMALL WINGS AT THE END AND ONE WING BROKE OFF FOLLOWING REPAIR. XRAY WITH CARM UTILIZED BY SURGEON TO TRY AND LOCATE PLASTIC WING TIP. SURGEON SAW QUESTIONABLE SHADOW ON XRAY AND ATTEMPTED TO FIND WING TIP WITH OPEN EXPLORATION OF OPERATIVE SITE. ATTEMPT WAS UNSUCCESSFUL. PT STAYED OVERNIGHT IN HOSPITAL AND PROCEDURE WAS PROLONGED BY APPROXIMATELY 3.5 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI SELF-RETAINING CANNULA NBH, ACCESSORIES, ARTHROSCOPIC NBH FRANTZ MEDICAL DEVELOPMENT, LTD. SR8 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R