BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX INSTRUMENT SET

    MDR report key: 2171911 · Received March 1, 2007

    Report

    Report Number
    2171911
    Event Type
    Injury
    Date Received
    March 1, 2007
    Date of Event
    February 21, 2007
    Report Date
    February 27, 2007
    Manufacturer
    ARTHREX
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD ACUTE ANTERIOR CRUCIATE LIGAMENT TEAR, RIGHT KNEE. SURGICAL REPAIR COMPLETED ON (B)(6) 2007. ON POST OP VISIT (B)(6) 2007, FOLLOW UP X-RAY DONE, NOTING RETAINED GUIDEWIRE RIGHT KNEE. PT HAD SURGICAL REMOVAL OF GUIDEWIRE ON (B)(6) 2007. ONCE REMOVED, GUIDEWIRE APPEARED TO HAVE BEEN BROKE OFF. RETAINED PIECE MEASURES 3" IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX INSTRUMENT SET NITINOL GUIDEWIRE HRX ARTHREX UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention