BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/RT-STER

    MDR report key: 3813221 · Received May 15, 2014

    Report

    Report Number
    3003506883-2014-10052
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 22, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK121601
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BEGINNING OF (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT # 7498317 OF 2.7/3.5 VA-LCP ALDT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE BREAKAGE OF THE VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIAL PLATE OCCURRED AT THE SECOND DISTAL COMBINATION PLATE HOLE. THE VA-LCP ANTEROLATERAL DISTAL TIBIAL PLATE IS MADE OF STAINLESS STEEL. 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 OF THE PLATE IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS (B)(4) FOR SURGICAL IMPLANTS MADE OF STAINLESS STEEL. THE DIMENSIONS OF THE INVESTIGATED VA-LCP ANTEROLATERAL DISTAL TIBIAL PLATE (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALLIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. THE WIDTH OF THE VA-LCP IS 13.29 MM AND THE THICKNESS IS 2.75 MM. ON THE THREADED PART OF THE FIRST DISTAL COMBINATION PLATE HOLE A FATIGUE CRACK IS VISIBLE. CORROSION MARKS WERE OBSERVED IN THE FOURTH DISTAL COMBINATION PLATE HOLE ON THE PROXIMAL FRAGMENT. THE CORROSION RESULTS FROM MICROMOVEMENT BETWEEN THE SCREW HEAD AND THE PLATE. THE MICROMOVEMENTS CAUSE DAMAGE TO THE PASSIVATION LAYER OF THE METAL AND CAN PANDER CREVICE CORROSION OR PITTING CORROSION. WHEN EXAMINING THE PROXIMAL FRACTURE SURFACES OF THE VA-LCP ANTEROLATERAL DISTAL TIBIAL PLATE USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR WERE IDENTIFIED. THE CRACK STARTED AT THE UPPER SIDE OF THE PLATE AND RAN INTO THE MATERIAL. DOCUMENTED FATIGUE CRACKS CLOSE TO THE INITIAL FRACTURE ZONES INDICATE MULTIPLE CRACK INITIATION. AFTER BREAKING, THE TWO PLATE FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING PARTLY DESTRUCTION OF THE FRACTURE SURFACES (ABRADED AND SHINY AREAS). AT A HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND OVER THE ENTIRE FRACTURE SURFACE. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT AND THEY ORIGINATE FROM CYCLIC LOADS (LOAD AND UNLOAD DURING WALKING). THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE PLATE FAILURE WAS CAUSED BY FATIGUE AND OVERLOAD. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, IT IS LIKELY THAT THE IMPLANT WAS SUBJECTED TO LOW DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING LOAD CYCLES LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE VA-LCP ANTEROLATERAL DISTAL TIBIAL PLATE. THE IMPLANT COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DISTAL ANTERO LATERAL TIBIAL PLATE BROKE. PATIENT WAS REVISED TO AN IMPLANT WITH LONGER PLATE OF THE SAME TYPE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290946 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/RT-STER PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 7498317

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention