BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 9MM

    MDR report key: 6431871 · Received March 24, 2017

    Report

    Report Number
    1219602-2017-00336
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    January 25, 2017
    Report Date
    April 6, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ASSESSMENT OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT OF BREAKAGE. THE DRILL HEAD HAS SPLIT IN TWO PIECES AND HAS COME FREE FROM THE DRILL SHAFT. THE BREAK IS A CLEAN SHEAR WITH A SLIGHT TWIST. THE ACTUATOR WIRE IS SPIRALED IN THE FORWARD DRILLING POSITION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. A ROOT CAUSE INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS FAILURE MODE. AFTER THE EVALUATION THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL REPAIR, THE BLADE POPPED OFF AND FELL IN THE KNEE. NO REPORTED PATIENT INJURIES. NO OTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215393 RETROGRADE DRL 9MM BIT, SURGICAL GFG SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR