BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3861440 · Received April 17, 2014

    Report

    Report Number
    3861440
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HEAD OF THE SCREW BROKE OFF DURING IMPLANTATION. ONLY THREADS OF THE SCREW IMPLANTED INTO PATIENT'S RIGHT FEMUR. THE BROKEN SCREW HEAD WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235813 * SCREW, IMPLANT HWC SYNTHES (USA) PRODUCTS LLC 04005526 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR