BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX

    MDR report key: 2212489 · Received March 28, 2008

    Report

    Report Number
    2212489
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 7, 2008
    Report Date
    January 18, 2008
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GUIDE PIN WAS "CHECKED" ONTO THE END OF THE DRILL AND UTILIZED FOR A TUNNEL PREP. THE REAMER WAS THEN INTRODUCED OVER THE GUIDE PIN. THE REAMER WAS REMOVED, THE SURGICAL TECH NOTICED THAT THE END WAS USED TO VISUALIZE THE PT FEMUR. THE PIECE REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX ACL TRANSTIBIAL KIT HRX 95598

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR