BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM FLEXSHAFT

    MDR report key: 3132524 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02389
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    February 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN ADDITIONAL EVALUATION WAS CONDUCTED BY SYNTHES GMBH AND THE REPORT INDICATES: THE MEASURABLE DIMENSIONS OF THE SYNREAM FLEXSHAFT WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. FURTHER, THE EXAMINATION OF THE MANUFACTURING DOCUMENTS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY, AND THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD FOR NITINOL (55NI-45TI). A VISUAL INSPECTION OF THE SYNREAM FLEXSHAFT CONFIRMED DAMAGE TO THE DEVICE AND REASONABLY SUGGESTS THAT THE REAMER HEAD EITHER CAME IN CONTACT WITH A METALLIC PART OR IT WAS NOT ACCURATELY ATTACHED ONTO THE FLEXSHAFT, RESULTING IN DEFORMATION OF THE FLEXSHAFT. ALSO, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES GMBH REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED SYNREAM SHAFT DAMAGED ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNREAM FLEXSHAFT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236037 SYNREAM FLEXSHAFT HTO SYNTHES GMBH 7812826

    Patients

    Seq Age Sex Outcome Treatment
    1