BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR Ø4 GREEN

    MDR report key: 3105065 · Received May 10, 2013

    Report

    Report Number
    8030965-2013-02179
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Report Date
    April 17, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTE
    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. THE REVIEW OF THE MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE INSTRUMENT WAS MANUFACTURED TO THE SPECIFICATIONS. A FUNCTIONAL TEST HAS SHOWN THAT THE INSTRUMENT FUNCTIONS PROPERLY. THE REVIEW WITH FUNCTION GAGES AND TEST MANDEL SHOWED NO DEVIATIONS. THE COMPLAINED FAILURE COULD NOT BE REPRODUCED. PLACEHOLDER.

    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE DISTAL SCREW REPEATEDLY MISSED THE NAIL. THIS CAUSED A SIGNIFICANT DELAY OF THE OR TIME, GREATER THAN 20 PERCENT. THE SURGEON CHANGED THE AIMING ARM FOR DYNAMIC LOCKING, AND THE SCREW COULD THEN BE INSERTED. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206417 TROCAR Ø4 GREEN KTE SYNTHES GMBH 2118381

    Patients

    Seq Age Sex Outcome Treatment
    1