BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 125° F/PFNA BLADE

    MDR report key: 3192619 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04136
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE REVIEW OF THE MANUFACTURING AND MATERIAL DOCUMENTS AND THE FUNCTIONAL TEST HAS SHOWN THAT THE PRESENT INSTRUMENT WAS MANUFACTURED TO THE SPECIFICATIONS AND FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SLEEVE IS JUMPING OUT OF THE AIMING DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294070 AIM-ARM 125° F/PFNA BLADE FZX SYNTHES GMBH 2618496

    Patients

    Seq Age Sex Outcome Treatment
    1