BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4484609 · Received February 4, 2015

    Report

    Report Number
    2520274-2015-10780
    Event Type
    Injury
    Date Received
    February 4, 2015
    Report Date
    January 22, 2015
    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

    ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. DEVICE 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

    A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT WHEN EXAMINING THE FRACTURE SURFACES OF THE DISTAL FRAGMENT (SEM A/B) OF THE PLATE USING SEM, THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR WERE IDENTIFIED. MULTIPLE CRACKS STARTED AT THE ANTEROLATERAL SIDE (UPPER SIDE) OF THE PLATE AT THE TRANSITION TO THE VA-LCP COMBI-HOLE ON BOTH SIDES OF THE HOLE AND RAN INTO THE MATERIAL. AFTER BREAKING, THE TWO FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING MORE DESTRUCTION OF THE FRACTURE SURFACES (ABRADED AND SHINY AREAS). AT HIGHER MAGNIFICATION, FATIGUE STRIATIONS WERE OBSERVED AT THE CRACK PROPAGATION ZONES AND OVER THE ENTIRE FRACTURE SURFACES. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT. THEY ORIGINATE FROM CYCLIC LOADS (LOAD AND UNLOAD DURING WALKING). THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. THE FRACTURE SURFACE SEM B ALSO SHOWED A SECONDARY CRACK INITIATION SITE AT THE LOWER SIDE OF THE PLATE, OPPOSITE OF THE INITIAL CRACK INITIATION SITE. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE PLATE FAILURE WAS CAUSED BY FATIGUE AND OVERLOAD. IN CONCLUSION: THE VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE 2.7/3.5 WAS IMPLANTED ON (B)(6) 2014 FOR THE TREATMENT OF A MULTIFRAGMENTARY DISTAL TIBIA FRACTURE. ACCORDING TO THE DEVICE REPORT, THE BREAKAGE OF THE PLATE WAS OBSERVED ON (B)(6) 2015, ONLY 3 MONTHS AFTER THE IMPLANTATION. PREVIOUSLY TAKEN X-RAYS SHOWED NO CALLUS FORMATION. THE REVISION SURGERY TO REMOVE THE BROKEN PLATE WAS PERFORMED ON THE (B)(6) 2015, FIXATION BY MEANS OF A RING FIXATOR. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, IT CAN BE CONCLUDED THAT THE PLATE WAS SUBJECTED TO LOW DYNAMIC BENDING LOADS, TWO SIDED. CONSTANTLY ALTERNATING BENDING LOADS / LOAD CYCLES (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO MULTIPLE CRACKS AND FINALLY TO THE FRACTURE OF THE PLATE. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. 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

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT IT REVEALED NO COMPLAINT RELATED ANOMALIES. THE (DHR) SHOWS THIS LOT OF 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/LT-STER WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE 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 NON-CONFORMANCES OR REWORK NOTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 IS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE (B)(6) REPORTS THE FOLLOWING: AN ANTEROLATERAL DISTAL TIBIA PLATE WAS IMPLANTED ON (B)(6) 2014, AT WHICH POINT THE PATIENT WAS NON-WEIGHT BEARING, STATUS PARTIAL WEIGHT BEARING AFTER 3 MONTHS. THE DEVICE BROKE BETWEEN (B)(6) 2014 AND (B)(6) 2015, AS IDENTIFIED BY X-RAY. THE PATIENT WAS REVISED TO A CIRCULAR FRAME ON (B)(6) 2015. THE SURGEON SUSPECTS THAT NOT ENOUGH SCREWS WERE IMPLANTED. THE PLATE BROKE AT A SCREW HOLE BUT NO SCREW WAS IMPLANTED THEREIN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82649 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/LT-STER PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 7307766

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention