BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR KNOTLESS

    MDR report key: 2061296 · Received April 18, 2011

    Report

    Report Number
    1219602-2011-00060
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DR. HAD AN EXCELLENT VIEW AND TRAJECTORY FOR THIS ANCHOR PLACEMENT, AND ALL WENT WELL UNTIL HE TURNED THE DIAL CLOCKWISE AND REMOVED THE INSERTER FROM BONE. ONCE HE DID THIS, HE HAD DIFFICULTY TURNING THE DIAL (THERE WAS A SOUND OF THE ANCHOR SPRINGING BACKWARD, MAKING IT DIFFICULT TO TURN BUT WE DID FINALLY GET 3 SOLID CLICKS). HE THEN MOVED THE SCOPE DIRECTLY OVER THE ANCHOR AND NOTICED METAL LEFT INSIDE THE ANCHOR. WE LOOKED AT THE INSERTER, AND THE PIECE THAT DEPLOYS THE PLUG INTO THE ANCHOR HAD BROKEN OFF AND WAS WEDGED IN THE CENTER OF THE ANCHOR. WE HAD NO CHOICE BUT TO LEAVE THIS METAL PIECE IN THE ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIORAPTOR KNOTLESS BIORAPTOR, KNOTLESS SUTURE ANCHOR MBI SMITH & NEPHEW ENDOSCOPY 72202403 50354669

    Patients

    Seq Age Sex Outcome Treatment
    1