BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 16663230 · Received April 3, 2023

    Report

    Report Number
    16663230
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 23, 2023
    Report Date
    March 23, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USING RIA 2 BONE HARVESTING KIT 520MM WITH 11.0MM REAMER HEAD FOR RIA 2 MD AT FIELD REPORTED BROKEN PIECE NOTED TO REAMER HEAD. REAMER HEAD WITH 3 OUT OF 4 PIECES REMOVED FROM USE. X-RAY USED INTRAOPERATIVELY. ONE PIECE VISIBLE ON X-RAY PER MD AND TO BE RETAINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530063 11.0MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO SYNTHES GMBH 03.404.018S 46P3492

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA Unknown