BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI SELF-RETAINING CANNULA

    MDR report key: 1821531 · Received August 27, 2010

    Report

    Report Number
    1526605-2010-00001
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 27, 2010
    Manufacturer
    FRANTZ MEDICAL DEVELOPMENT, LTD.
    Product Code
    NBH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EVALUATION OF THE RETURNED DEVICE CONFIRMED THE WINGS AT THE DISTAL END OF THE CANNULA BROKE OFF. 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 FAILURE TO REMOVE THE OBTURATOR PRIOR TO WING DEPLOYMENT AND THE USE OF EXCESSIVE AXIAL FORCE. GEMINI SELF-RETAINING CANNULA, INSTRUCTION FOR USE (PG3): ONCE THE CANNULA ASSEMBLY IS IN THE CORRECT POSITION WITHIN THE JOINT, HOLD THE INNER CANNULA POSITION AND REMOVE THE OBTURATOR FROM THE ASSEMBLY. USING A SYRINGE INJECTION MOTION, PUSH THE INNER CANNULA FORWARD WITH THE PALM OF THE HAND WHILE PULLING AGAINST THE OUTER CANNULA TOWARDS THE PALM OF THE HAND WITH THE INDEX AND MIDDLE FINGER. NOTE: IF EXCESSIVE FORCE IS REQUIRED FOR WING DEPLOYMENT, VERIFY THAT THE CANNULA IS PROPERLY PLACED WITHIN THE SURGICAL SITE BEFORE CONTINUING TO APPLY FORCE. CONTINUE TO PULL BACK ON THE OUTER CANNULA FOR WING DEPLOYMENT. 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

    THE WINGS OF THE CANNULA BROKE OFF AS THE SURGEON WAS PUSHING THE OBTURATOR TO DEPLOY. THE SURGEON HAD TO LENGTHEN THE INCISION TO LOOK FOR BROKEN PIECES WHICH WERE FOUND TO BE ON THE FLOOR. SURGERY WAS COMPLETED. ROTATOR CUFF REPAIR.

    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 35 YR Required Intervention