BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE RADIOLUC F/PFNA

    MDR report key: 3180642 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03662
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    January 26, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE EVALUATION REVEALED THAT THE COMPLAINED INSTRUMENT SHOWS FULL CONFORMITY TO THE SPECIFICATIONS. CARRIED OUT FUNCTIONAL TESTS CAME TO THE RESULT THAT INSTRUMENT WORKS FINE. WE HAVE TO ASSUME THAT OTHER COMPLICATIONS MAY HAVE CAUSED THE PROBLEMS. MAY BE THE AIMING ARM WAS NOT ASSEMBLED CORRECTLY OR HIGH FORCE FROM SOFT TISSUES ON THE PROTECTION SLEEVE CAUSED DEVIATION. NO PRODUCT FAULT COULD BE DETECTED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS DEVIATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279805 INSERT-HANDLE RADIOLUC F/PFNA LXH SYNTHES GMBH 3444949

    Patients

    Seq Age Sex Outcome Treatment
    1