BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM/EXT-FIX RADIOLUC

    MDR report key: 3192532 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03749
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    September 2, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION SHOWED THAT THE CLAMPS INDEED HAVE SOME DAMAGES DUE TO POSSIBLE OVER TIGHTENING. WE HAVE SENT THE RETURNED ITEMS BACK TO OUR MANUFACTURER; THERE WE WERE NOT ABLE TO COMPREHEND THE MENTIONED PROBLEMS. ALL MEASUREMENTS AND TESTS CONFIRM THAT THESE PARTS WERE MANUFACTURED ACCORDING TO THE GIVEN SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. NOTE THAT THE DAMAGED PARTS HAVE BEEN DISPOSED BY THE MANUFACTURER AFTER TESTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMPS STARTED TO GET LOOSE. CLAMPS AND DISPOFIX, WERE LOOSEN, AND FIXATION WAS REATTEMPTED USING DISPOFIX IN (B)(6) 2011. IN THE OPERATION ONLY THE FRAME WAS EXCHANGED TO REDUCE AND STABILIZE THE FRACTURE. ONE WEEK LATER, ONE OF THE CLAMPS HAD TO BE REFASTENED REPEATEDLY OVER TIME. FURTHER, OTHER CLAMPS IN THE SYSTEM STARTED LOOSENING, WHICH CAUSED DIFFICULTY TO RETAIN THE FRACTURE REDUCING POSITION. ALTHOUGH THE DISPO-FIX WAS USED MORE THAN ONE MONTH, IT WAS REMOVED AT THE SECOND WEEK OF OCTOBER, AFTER INFECTION WAS FOUND AT THE CELL DRILL INSERTION AREA. BONE UNION HAD NOT YET BEEN COMPLETED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292250 SM/EXT-FIX RADIOLUC HRS SYNTHES GMBH 3526900

    Patients

    Seq Age Sex Outcome Treatment
    1