BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4 MMX15 IN. DRILL TIP PASS. PIN PKG 6

    MDR report key: 539954 · Received March 26, 2004

    Report

    Report Number
    1219602-2004-00031
    Event Type
    Malfunction
    Date Received
    March 26, 2004
    Date of Event
    February 4, 2004
    Report Date
    March 25, 2004
    Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIV.
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ACLI REPAIR THE PASSING PIN BROKE OFF IN THE PT'S FEMUR. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PIECE FROM THE PT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE REPAIR. A DELAY OF THIRTY MINS RESULTED FROM THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4 MMX15 IN. DRILL TIP PASS. PIN PKG 6 PASSING PIN HXI SMITH & NEPHEW INC. ENDOSCOPY DIV. 014604 50007313

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other