BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XL SUTURE CUTTER

    MDR report key: 6113557 · Received November 18, 2016

    Report

    Report Number
    3003604053-2016-00109
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY THE SUPPLIER AND COULD CONFIRM THE CUSTOMER COMPLAINT FOR THE INSTRUMENT POPPED. A VISUAL INSPECTION WAS PERFORMED AND SHOWED THAT THE SHEAR PIN THAT CONNECTS THE LEVER TO THE ACTUATOR WAS SHEARED OFF. IN THIS CONDITION, THE LEVER WILL MOVE BUT NOT DRIVE THE ACTUATOR AND RENDER THE DEVICE UNABLE TO CUT THE SUTURE. CUTTER SHAFT EDGES SHOW NORMAL WEAR AT CUTTING EDGES AND NO SIGNS THAT THE DEVICE WAS USED TO CUT ANY MATERIAL OTHER THAN ITS INTENDED USE. DAMAGE TO THE CUTTER ACTUATOR SLOTS INDICATES THE DEVICE WAS SUBJECTED TO EXCESSIVE FORCE BEYOND IT INTENDED USE. THE CUTTING EDGE AND CUTTER SHAFT ARE RELATIVELY INTACT SO MOST LIKELY THE FAILURE IS THE RESULT OF ATTEMPTING TO CUT TOO MANY SUTURES AT ONE TIME. THIS WOULD PREVENT THE CUTTER FROM MOVING INTO THE CUT ZONE AND CAUSE A FAILURE OF THE SHEAR PIN SAFETY DEVICE. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON MAY HAVE SQUEEZED THE DEVICE TOO HARD AND THE INSTRUMENT POPPED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764385 XL SUTURE CUTTER ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 30694

    Patients

    Seq Age Sex Outcome Treatment
    1