BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCS 95° 14HO L242 SST

    MDR report key: 3123620 · Received May 22, 2013

    Report

    Report Number
    3003506883-2013-00229
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HRS. AN ADDITIONAL EVALUATION WAS COORDINATED BY SYNTHES (B)(4); PERFORMED BY RMS AND THE REPORT (ENGINEERING EXAMINATION ¿ REPORT (B)(4)) STATES THE FOLLOWING: THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEET OF THE SUPPLIER AND THE MANUFACTURING DOCUMENTS OF THE PRODUCER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. CONSTANTLY ALTERNATING BENDING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE PLATE (EXAMINATION PERFORMED UTILIZING SCANNING ELECTRON MICROSCOPE, SEM). THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT AND INSTABILITY OF THE FRACTURE SITUATION MAY HAVE PLAYED A CERTAIN ROLE TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. FURTHER, A MANUFACTURING EVALUATION WAS PERFORMED AND THE REPORT STATES THE FOLLOWING: INSPECTION/MEASUREMENT OF THE RETURNED PART SHOWED THAT IT MEETS ALL DIMENSIONAL REQUIREMENTS FOR UNDAMAGED PERTINENT FEATURES. DUE TO THE RETURNED PART CONDITION, THE DAMAGED FEATURES ARE NOT MEASURABLE, SO THIS COMPLAINT IS DEEMED INDETERMINATE. EXPLANT WAS REPORTED AS (B)(6) 2013, THIS IS INCORRECT AS THE CORRECT DATE SHOULD BE (B)(6) 2013.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS TREATED FOR A SUBTROCHANTERIC FRACTURE OF THE FEMUR ON AN UNKNOWN DATE. AN OPEN REDUCTION INTERNAL FIXATION (O.R.I.F.) WITH A DYNAMIC CONDYLAR SCREW (DCS) PLATE WAS IMPLANTED. TWO MONTHS LATER ON AN UNKNOWN DATE, THE PATIENT WAS WALKING WITH CRUTCHES (WALKER) AND FELT PAIN. IT WAS DISCOVERED THAT THE PLATE HAD FRACTURED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225989 DCS 95° 14HO L242 SST KTT SYNTHES ELMIRA 7050176

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention