BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM/EXT-FIX RADIOLUC

    MDR report key: 3131723 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02460
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 1, 2011
    Report Date
    February 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. SIX DEVICES WERE SENT TO THE SUPPLIER FOR EVALUATION AND THE VISUAL INSPECTION AND PRODUCT EVALUATION REVEALED THAT IN 3 OUT OF THE 6 CLAMPS THE NUTS CANNOT BE MOVED DUE TO A DEFORMATION IN THE NUT THREAD. IN THE OTHER 3 CLAMPS THE NUTS CAN ROTATE DESPITE THE DEFORMATION OF THE FLANGE. ACCORDING TO THE DRAWING THE FLANGE OF THE THREADED PIN IS DEFORMED, SO THAT THE NUT CAN NO LONGER BE ROTATED. DURING THE INVESTIGATION, IT WAS IDENTIFIED THAT THE NUTS WERE NOT ASSEMBLED CORRECTLY. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED AND THE FOLLOWING ACTION HAS OCCURRED. THE ASSEMBLING TOOL WAS ADAPTED WITH POKA YOKE-STANDARD AND THE QUALITY DOCUMENTS WERE COMPLETED WITH PICTURE ILLUSTRATIONS AND THE RESPONSIBLE STAFF WAS TRAINED USING THE NEW TOOLS AND DOCUMENTS. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND THE COMPLAINT CONDITION IS DUE TO PERSONNEL ERROR, WHEREBY THE ASSEMBLING OF THE CLAMP FLANGES WERE NOT EXECUTED ACCORDING TO THE REQUIREMENTS AND THE PROCEDURE WAS NOT FOLLOWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMPS DID NOT WORK RIGHT FROM THE START. THE NUTS OF THE CLAMPS WERE NOT ABLE TO BE ROTATED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234483 SM/EXT-FIX RADIOLUC KWP SYNTHES GMBH 3565648

    Patients

    Seq Age Sex Outcome Treatment
    1