BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASHERLOC CANCELLOUS SCREW

    MDR report key: 694703 · Received March 31, 2006

    Report

    Report Number
    2027970-2006-00004
    Event Type
    Injury
    Date Received
    March 31, 2006
    Date of Event
    February 2, 2006
    Report Date
    March 2, 2006
    Manufacturer
    ARTHROTEK, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE INSTALLING CANCELLOUS SCREW INTO PATIENT'S TIBIA FOR ACL RECONSTRUCTION, TOP 1/3 OF SCREW BROKE OFF. BOTTOM 2/3 OF SCREW REMAINED IN PATIENT'S TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WASHERLOC CANCELLOUS SCREW 48MM X6MM CANCELLOUS SCREW HWC ARTHROTEK, INC. 908848 L234170

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention