BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L360

    MDR report key: 2822630 · Received November 7, 2012

    Report

    Report Number
    8030965-2012-01204
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM OBERDORF INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, THE TIP IF THE RIA DRIVE SHAFT BROKE OFF. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIA DRIVESHAFT L360 RIA DRIVESHAFT KTT SYNTHES GMBH 14902-01

    Patients

    Seq Age Sex Outcome Treatment
    1