BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE

    MDR report key: 3193280 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02376
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    August 20, 2010
    Report Date
    January 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. ADDITIONAL EVALUATION: THE BROKEN RECONSTRUCTION PLATE WAS RECEIVED FOR EVALUATION. THE OBLIQUE FRACTURE OF THE RECONSTRUCTION PLATE TOOK PLACE AT THE FIFTH COMBINATION PLATE HOLE (DCU PORTION AND THREAD). THE MEASUREMENT OF THE RECONSTRUCTION PLATE MEASURED ACCORDING TO THE TECHNICAL DRAWINGS OF THE MANUFACTURER AND THE AO/ASIF SPECIFICATIONS. THE CHEMICAL COMPOSITION OF THE RECONSTRUCTION PLATE WAS TESTED QUALITATIVELY WITH EDX AND CORRESPONDS TO A TYPICAL COMPOUND FOR THIS MATERIAL (PURE TITANIUM, GRADE 4). THE BREAK SURFACES WERE EXAMINED UNDER THE SCANNING ELECTRON MICROSCOPE. FATIGUE CRACKS IN THE AREA OF THE BREAK INTRODUCTION ZONE WERE DOCUMENTED, AND POINT TO A MULTIPLE CRACK INTRODUCTION DUE TO OVERLOADS. THE BREAK SURFACES WERE PARTIALLY DAMAGED (GRATED, FLAT PORTIONS). THIS MAKES IT CLEAR THAT THE BREAK SURFACES HAD RUBBED AGAINST ONE ANOTHER FOR A PERIOD OF TIME. THE OBSERVATIONS AND CONNECTIONS CLEARLY POINTED TO MATERIAL FATIGUE DUE TO CYCLIC OVERLOADS ON THE INVESTIGATED RECONSTRUCTION PLATE. IT WAS ASSUMED THAT THE RECONSTRUCTION PLATE FUNCTIONED AS THE SOLE LOAD CARRIER. CHANGING DEMANDS DURING THE LOADS HAVE LED TO FATIGUE OF THE MATERIAL AND A BREAK OF THE IMPLANT. THE PLATE COULD NOT HOLD UP AGAINST THE LOAD EFFECTS WHICH TOOK PLACE, WHICH FINALLY LED TO A FAILURE OF THE IMPLANT AS A CONSEQUENCE OF THE MATERIAL OVERLOAD AND FATIGUE. NO EVIDENCE OF MATERIAL OR MANUFACTURING MISTAKE WAS FOUND IN THE RECONSTRUCTION PLATE WHICH WE EXAMINED.

    Description of Event or Problem · 1

    LCP-PLATE BROKEN OFF AFTER 8 WEEK POST-OP, INCLUDING RE-FRACTURING OF THE COLLARBONE. THIS MADE IT NECESSARY FOR OUR CLIENT TO STAY IN YOUR HOSPITAL A SECOND TIME AS AN IN-PATIENT. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294629 LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE KTT SYNTHES GMBH 3331132

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention