BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR F/CERCL-PASSER NOS. 03.221.010+03

    MDR report key: 3143448 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02643
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    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. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE PERFORMED INVESTIGATION SHOWED A BREAKAGE OF THE WIRE DIRECTLY BELOW THE HANDLE. BECAUSE OF THE DAMAGE SYMPTOMS THE EXACT CAUSE CANNOT BE ELICITED. IT IS POSSIBLE THAT THE TEMPORARY MECHANICAL OVERLOAD WAS LEADING TO THIS DAMAGE. A REVIEW OF THE MATERIAL AND MANUFACTURING DOCUMENTS SHOWED NO DEVIATION ACCORDING TO THE AO / ASIF SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, A TROCAR BROKE. IT IS UNKNOWN WHERE THIS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245381 TROCAR F/CERCL-PASSER NOS. 03.221.010+03 LXH SYNTHES GMBH 2708859

    Patients

    Seq Age Sex Outcome Treatment
    1