BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1904025 · Received October 18, 2010

    Report

    Report Number
    1904025
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 18, 2010
    Manufacturer
    SYNTHES
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING TOTAL HIP REPLACEMENT, A PIECE OF METAL BROKE OFF THE MALLET BEING USED. THE METAL WAS RETRIEVED. THERE WAS NO HARM TO THE PATIENT. THE PHYSICIAN HAS NOT EXPERIENCED THIS TYPE OF PROBLEM WITH THIS MALLET IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MALLET, ORTHOPEDIC HXL SYNTHES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR