BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARPOON SUTURE ANCHOR

    MDR report key: 95461 · Received May 29, 1997

    Report

    Report Number
    95461
    Event Type
    Injury
    Date Received
    May 29, 1997
    Date of Event
    May 19, 1997
    Report Date
    May 22, 1997
    Manufacturer
    BIOMET, INC., DISTRIBUTED BY ARTHROTEK
    Product Code
    KGS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HARPOON SUTURE TECHNIQUE USED FOR TRANSPOSITION ULNA COLLATERAL LIGAMENT. WHEN SURGEON USED MALLET TO INSERT SECOND HARPOON SUTURE, THE MEDIAL CONDYLE FRACTURED. SECOND HARPOON SUTURE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARPOON SUTURE ANCHOR SUTURE ANCHOR #2 KGS BIOMET, INC., DISTRIBUTED BY ARTHROTEK * 361220

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention