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: 5229329 · Received November 17, 2015

    Report

    Report Number
    2520274-2015-17325
    Event Type
    Injury
    Date Received
    November 17, 2015
    Report Date
    October 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DISTAL TIBIA PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. (B)(6). 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. 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 MANUFACTURING EVALUATION WAS COMPLETED: A VISUAL INSPECTION OF THE PLATE SHOWS THE PART IS BROKEN INTO TWO PIECES. THE BREAK RUNS ACROSS THE VARIABLE ANGLE HOLE. MARKS AND SCRATCHES ARE PRESENT ON TOP AND BOTTOM SURFACES OF THE PLATE. PART RAW MATERIAL WAS VERIFIED AND FOUND CONFORMING. PART HOLES WERE INSPECTED FOR LENGTH, WIDTH, WALL THICKNESS, DIAMETER DEPTH, THREAD MINOR DIAMETER. SEVERAL OF THE THREADS WERE DAMAGED AND THE BREAK RAN THROUGH ONE OF THE HOLES. THE FEATURES FOR THE NON-DAMAGES HOLES WERE ALL CONFORMING. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE X-RAY PROVIDED WAS REVIEWED. THE PLATE FAILURE IS AT THE 4TH SCREW HOLE FROM THE DISTAL END CENTERED ON THE COMBI-HOLE. THERE APPEARS TO BE NO SCREW PRESENT IN THIS HOLE AND THERE IS NO MENTION OF SCREW FAILURE NOR DOES IT APPEAR THAT SCREWS HAVE FAILED IN ANY WAY. THE PLATE FRACTURE LOCATION IS THE WHERE THE MOST STRESSES ARISE AND WHERE A PLATE WOULD MOST LIKELY BREAK IN BENCH TESTING UNDER A CONTROLLED LOAD. THE POST-OPERATIVE X-RAY ON THE 14TH WEEK FOLLOW UP SUPPORTS A DIAPHYSEAL/METAPHYSEAL COMMINUTED FRACTURE OF THE LEFT TIBIA OF A PATIENT WHO IS (B)(6), NO OTHER PATIENT CHARACTERISTICS SUCH AS WEIGHT ARE PROVIDED. NOTES IN THE COMPLAINT REPORT STATE THE PATIENT WAS 25% MOBILE. BASED ON THE CONTENT OF THE COMPLAINT SUMMARIZED ABOVE THE PLATE LIKELY FRACTURED AS A RESULT OF MAL OR NON-UNION COMBINED WITH CYCLICAL LOADING FROM A PARTIALLY MOBILE PATIENT AT A LOCATION CONSISTENT WITH THE MOST MECHANICAL STRESS UNDER NORMAL CIRCUMSTANCES. A PRODUCT INVESTIGATION WAS COMPLETED: THE MEASURABLE DIMENSIONS OF THE PLATE WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING, DIMENSIONS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARDS FOR STAINLESS STEEL. A MANUFACTURING AND A DESIGN RELATED EVALUATION WAS PERFORMED AND NO PRODUCT FAULT COULD BE DETECTED. BASED ON THE PROVIDED INFORMATION IT IS LIKELY THAT THE PLATE LIKELY FRACTURED AS A RESULT OF MAL OR NON-UNION COMBINED WITH CYCLICAL LOADING FROM A PARTIALLY MOBILE PATIENT AT A LOCATION CONSISTENT WITH THE MOST MECHANICAL STRESS UNDER NORMAL CIRCUMSTANCES. NEITHER A MANUFACTURING NOR A DESIGN RELATED ISSUE WAS DETECTED. 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

    OTHER: UDI NUMBER: (B)(4). ORIGINAL PART MANUFACTURE DATE: 06 JUNE 2014. PART EXPIRATION DATE: 01 MAY 2024. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT 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 AT TIME OF ACCEPTANCE. NO NONCONFORMING REPORTS WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 TIBIA PLATE FRACTURED; IT WAS DETECTED AT THE FOURTEEN (14) WEEK FOLLOW-UP. PATIENT WAS 25% WEIGHT BEARING AT THE TIME. THE DEVICE WAS REPORTEDLY EXPLANTED ON (B)(6) 2015. THIS REPORT IS FOR AN UNKNOWN DISTAL TIBIA PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANT WAS REVISED ON (B)(6) 2015 FOR AN EXPERT TIBIAL NAIL. IT WAS REPORTED THE PATIENT OUTCOME IS ABSOLUTELY FINE AND SUFFERED NO HARM AS A RESULT OF THE PLATE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759165 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/LT-STER PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 7682726

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention