BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY SYNTHES RIA MEDULLARY REAMER HEAD 12.5 MM REAMER HEAD FOR RIA 2

    MDR report key: 23109646 · Received September 22, 2025

    Report

    Report Number
    MW5176287
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 16, 2025
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    HTO
    UDI-DI
    10886982273963
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEPUY REAMER HEAD BROKE OFF WHILE DOCTOR WAS SIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171218 DEPUY SYNTHES RIA MEDULLARY REAMER HEAD 12.5 MM REAMER HEAD FOR RIA 2 REAMER HTO DEPUY SYNTHES, INC. 352.125 FOR 12.5MM REAMER HEAD 10886982273963

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female