BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIA DRIVESHAFT L520

    MDR report key: 3171632 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02994
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    January 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DEVICE WAS RECEIVED AND THE FRACTURE WAS CONFIRMED. THE FRACTURE FACE IS HOMOGENEOUS WHICH INDICATES MATERIAL CONFORMITY. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SYNTHES IS NOT AWARE OF ANY OTHER COMPLAINT REGARDING THIS LOT. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN FRANCE AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF INSTRUMENT BROKE OFF. 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
    272462 RIA DRIVESHAFT L520 HTO SYNTHES GMBH 14656-01

    Patients

    Seq Age Sex Outcome Treatment
    1