BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 10MM

    MDR report key: 6350158 · Received February 22, 2017

    Report

    Report Number
    1219602-2017-00218
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 16, 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

    AWAITING RECEIPT OF DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED DRILL BIT BROKE INTO THREE PIECES IN THE TIBIAL TUNNEL. NO ADDITIONAL PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133817 RETROGRADE DRL 10MM BIT, SURGICAL GFG SMITH & NEPHEW, INC. G10378

    Patients

    Seq Age Sex Outcome Treatment
    1