BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES (USA) RIA SYSTEM

    MDR report key: 6684073 · Received July 3, 2017

    Report

    Report Number
    6684073
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Date of Event
    June 5, 2017
    Report Date
    June 6, 2017
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PIECE OF REAMING SUPPLY BROKE INSIDE OF PATIENT DURING PROCEDURE, BUT WAS NOT RETAINED IN PATIENT. PROCEDURE WAS FEMUR NONUNION REPAIR. SYNTHES RIA TUBE ASSEMBLY ITEM # 314.746S AND LOT # H252065 BROKE WHILE IN PATIENT. IT WAS REMOVED FROM THE PATIENT. NOTHING LEFT BEHIND. SYNTHES IS AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465286 SYNTHES (USA) RIA SYSTEM REAMER HTO SYNTHES (USA) PRODUCTS LLC 314.746S H252065

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR