BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR KNOTLESS

    MDR report key: 1893473 · Received November 8, 2010

    Report

    Report Number
    1219602-2010-00277
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION.(B)(4)

    Description of Event or Problem · 1

    DURING A SLAP REPAIR THE SURGEON DROVE WITH A 2.9 DRILL, THEN THEY WENT TO TAP IT IN AND THE ANCHOR BROKE AT THE EYELET. THEY HAD TO PULL OUT THE ANCHOR AND RELOAD ANOTHER ONE. IT HAPPENED AGAIN. THEY WERE SUCCESSFUL ON THE 3RD ATTEMPT. IT WAS CONFIRMED THAT NOTHING REMAINS IN THE PATIENT UNSUPPORTED. THE DRILL WAS A SPADE TIP STYLE. THE PATIENT HAD AVERAGE BONE QUALITY. SALES REP. BELIEVES THE SURGEON WAS OFF ANGLE AFTER REMOVING THE DRILL AND INSERTING THE ANCHOR AS THERE IS NO DRILL GUIDE USED WITH THIS PRODUCT AT THIS TIME. SURGERY WAS COMPLETED BY DRILLING ANOTHER HOLE AND USING ANOTHER ANCHOR. ULTIMATELY THERE WERE THREE HOLES DRILLED AND ONE ANCHOR PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIORAPTOR KNOTLESS BIORAPTOR, KNOTLESS SUTURE ANCHOR HWC SMITH & NEPHEW ENDOSCOPY 72202403 50346872

    Patients

    Seq Age Sex Outcome Treatment
    1