BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 2964100 · Received February 15, 2013

    Report

    Report Number
    1719045-2013-00340
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # 5471386 REVEALED THE DRIVE SHAFT ASSEMBLY WAS MANUFACTURED AND INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: PATIENT WITH GIANT CELL TUMOR IN THE LEFT FEMUR, WITH BONE DEFECT, MUST BE COMPLETED WITH GRAFT. SURGEON REAMED 10 CM AND THE RIA DRIVE SHAFT BROKE AT THE TIP. SURGEON DECIDED TO USE ANOTHER IMPLANT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66409 RIA DRIVESHAFT L520 RIA DRIVESHAFT HTO SYNTHES MONUMENT 14780-01

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR