BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG ANGLED BLADE PLATE 4 HOLES/70MM/60MM

    MDR report key: 3935519 · Received July 15, 2014

    Report

    Report Number
    1000562954-2014-10136
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    KTW
    PMA / PMN Number
    PK914546
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 PLATE OCCURRED THROUGH THE BLADE, APPROXIMATELY 22 MM AFTER THE BEND (PROXIMAL PART). THE CHEMICAL COMPOSITION OF THE PLATE WAS TESTED BY EDX (QUALITATIVE). THE PLATE WAS FOUND TO BE MADE OF STAINLESS STEEL AND CAN BE COMPARED WITH THE GERMAN MATERIAL (B)(4). THIS STEEL USED FOR SURGICAL IMPLANTS IS AN AUSTENITIC STAINLESS STEEL. A SMALL PORTION OF THE PLATE WAS SECTIONED AND PREPARED INTO A TRANSVERSAL AND LONGITUDINAL MICRO-SECTION. THE TRANSVERSE MICRO-SECTION SHOWED A HOMOGENEOUS AUSTENITIC MICRO-STRUCTURE. THE DETERMINATION OF THE NON-METALLIC INCLUSIONS (LONGITUDINAL MICRO-SECTION) WAS CARRIED OUT. THE RESULTS OF THE NON-METALLIC INCLUSIONS ARE IN ACCORDANCE WITH THE INTERNATIONAL STANDARDS ISO5832-1 / ASTM F138 AND THE SYNTHES SPECIFICATION FOR IMPLANTS MADE OF STAINLESS STEEL. THE MICRO-STRUCTURE IS FREE OF DELTA-FERRITE AND SIGMA PHASES AT A MAGNIFICATION OF 100 TIMES. BASED ON THESE RESULTS IT CAN BE CONCLUDED THAT THE CHEMICAL COMPOSITION AND MICROSTRUCTURE OF THE PLATE ARE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS ISO 5832-1 AND ASTM F138 FOR IMPLANTS MADE OF MATERIAL (B)(4). HARDNESS MEASUREMENTS WERE CARRIED OUT AND CORRESPONDED TO THE REQUIRED MINIMUM VALUE OF 860 MPA OF THE LATEST VERSION OF THE INTERNATIONAL STANDARDS ISO 5832-1 AND ASTM F138. THE DIMENSIONS OF THE INVESTIGATED PLATE WERE CHECKED USING A DIGITAL SLIDING CALLIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. DOCUMENTED MECHANICAL DAMAGE WAS OBSERVED AT THE BEND OF THE PLATE. WHEN EXAMINING THE FRACTURE SURFACE OF THE PLATE USING SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR WERE IDENTIFIED. THE CRACK STARTED AT THE PROXIMAL (UPPER SIDE) OF THE PLATE AND RAN INTO THE MATERIAL. MULTIPLE CRACK INITIATIONS WERE OBSERVED AT THE PLATE SURFACE. A SECONDARY CRACK INITIATION SITE WAS LOCATED AT THE DISTAL (BOTTOM SIDE) OF THE PLATE, ALSO WITH ADDITIONAL MULTIPLE CRACKS. AT HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND ALMOST 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. FURTHERMORE, THE FRACTURE SURFACE SHOWED SUBSIDIARY CRACKS AND FEW DIMPLES. THE SMALL AREA WITH DIMPLES CORRESPONDS TO THE RESIDUAL FORCED FRACTURE ZONE. DOCUMENTED FATIGUE CRACKS CLOSE TO THE INITIAL FRACTURE ZONE INDICATE MULTIPLE CRACK INITIATION. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE PLATE FAILURE WAS CAUSED BY FATIGUE AND OVERLOAD. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, IT CAN BE CONCLUDED THAT THE PLATE WAS SUBJECTED TO ALTERNATING BENDING LOADS, TWO-SIDED. CONSTANTLY ALTERNATING BENDING LOADS / LOAD CYCLES (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE FATIGUE FRACTURE OF THE PLATE. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. 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 THAT THE BLADE PLATE FRACTURED AT BLADE ROOT. BLADE PLATE FRACTURE IN SITU FOR SIX WEEKS, THE PATIENT WAS NOT YET FULLY WEIGHT BEARING. ON (B)(6), 2014 THE PATIENT WAS ADMITTED FOR A REVISION AND FIXATION PROCEDURE. THE ORIGINAL SURGERY WAS ON (B)(6), 2014 ON A (B)(6) GIRL WITH NO OTHER HEALTH PROBLEMS. FOUR WEEKS LATER SHE PRESENTED WITH PAIN AND WAS REVISED ON (B)(6), 2014. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414078 130 DEG ANGLED BLADE PLATE 4 HOLES/70MM/60MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT KTW SYNTHES MEZZOVICO 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention