BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINVATEC TWO PIN PASSER

    MDR report key: 35600 · Received July 9, 1996

    Report

    Report Number
    35600
    Event Type
    Malfunction
    Date Received
    July 9, 1996
    Date of Event
    January 11, 1996
    Report Date
    January 15, 1996
    Manufacturer
    LINVATEC CORP.
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR OF LT KNEE, WHILE DRILLING THE PIN PASSER THROUGH THE FEMUR, THE TROCAR TIP OF THE PIN BROKE OFF. THE TIP BECAME LODGED IN SOFT TISSUE AT PIN'S EXIT. FLOUROSCOPY WAS REQUIRED TO LOCATE THE TIP AND EXTRACTION WAS PERFORMED THROUGH AN ADD'L WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINVATEC TWO PIN PASSER TWO PIN PASSER HXI LINVATEC CORP. * 16303

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other