BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND F/SYNCAGE TRIAL IMPL STRAIG

    MDR report key: 3160557 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-03052
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    June 20, 2012
    Report Date
    July 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. VISUAL INVESTIGATION OF THE SUBJECT INSTRUMENT SHOWED THAT THE WELDING SEAM OF THE THREAD SPINDLE BROKE OFF. ACCORDING TO THE TRACES (STRONG HAMMER BLOWS ON THE HANDLE) WE ASSUME, THAT THE DAMAGE WAS CAUSED BY EXCESSIVE MECHANICAL LOAD. THE INSTRUMENT WAS EXAMINED ACCORDING TO MANUFACTURING AND MATERIAL DOCUMENTATION; THIS RESULTED IN THE CONCLUSION THAT ALL SPECIFICATIONS WERE ACCURATE. BASED ON THESE RESULTS WE CAN EXCLUDE ANY MANUFACTURING ERROR. NO PRODUCT ERROR COULD BE ESTABLISHED. THIS COMPLAINT IS INVALID. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    WELD OF SHAFT BROKE OFF. THE INNER PIECE BROKE OFF DURING SURGERY, WITH LITTLE FORCE. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259891 HAND F/SYNCAGE TRIAL IMPL STRAIG LXH SYNTHES GMBH 1698085

    Patients

    Seq Age Sex Outcome Treatment
    1