BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 H/LT-STER

    MDR report key: 5338549 · Received December 31, 2015

    Report

    Report Number
    3003506883-2015-10205
    Event Type
    Injury
    Date Received
    December 31, 2015
    Report Date
    December 11, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: DATE OF EVENT WAS REPORTED AS (B)(6) 2015; HOWEVER, IT IS UNKNOWN IF THIS WAS THE ACTUAL DATE THE PLATE BROKE OR IF THIS WAS THE DATE THE BROKEN PLATE AND NON-UNION OF THE FACTURE WERE DISCOVERED. (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF VA-LCP ANTEROLATERAL DISTAL TIBIA PLATES 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 INVESTIGATION RESULTS OF THE RETURNED PRODUCT ARE PENDING. 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

    AGE NOT PROVIDED BY REPORTER. UNKNOWN WHEN NON-UNION ACTUALLY OCCURRED, IT WAS REPORTED DURING THE 3RD REVISION WHEN THE NONUNION AND BROKEN PLATE WAS OBSERVED. DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 THE: FAILURE NON-UNION AND BROKEN PLATE WAS OBSERVED POST-OPERATIVE. DIMENSION THE MEASURABLE DIMENSIONS OF THE PLATE WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. MATERIAL 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 AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-1. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. CONCLUSION NO PRODUCT FAULT COULD BE DETECTED. THE LOT IN QUESTION WAS MANUFACTURED WITH A LOT SIZE OF (B)(4) PIECES IN APRIL 2014 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. IT IS LIKELY THAT ANY OCCURRENCE DURING THE HEALING PROCESS, LIKE THE MENTIONED NON-UNION, DID LEAD TO A FATIGUE FAILURE OF THE PLATE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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

    ADDITIONAL INFORMATION AND CLARIFICATION WERE RECEIVED ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL PLATE AND TWELVE (12) SCREWS TO TREAT A DISTAL TIBIA FRACTURE ON (B)(6) 2015. A SECOND, PLANNED REVISION SURGERY WAS PERFORMED APPROXIMATELY THREE MONTHS AFTER THE INITIAL SURGERY. THIS SURGERY WAS ROUTINE REVISION AND WAS PART OF THE TREATMENT AND MONITORING PLAN. THERE WAS NO ALLEGATION OF DEVICE COMPLAINT AT THIS TIME. THE THIRD REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 TO ADDRESS THE BROKEN VA-LCP AND NON-UNION. THE BROKEN PLATE WAS REMOVED DURING THE (B)(6) 2016 SURGERY ALONG WITH THE TWELVE INTACT SCREWS. THERE WAS NO ALLEGATION OF COMPLAINT AGAINST THE SCREWS.

    Description of Event or Problem · 1

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A FRACTURE OF DISTAL TIBIA FIXED WITH VA-LCP ANTEROLATERAL PLATE WAS PERFORMED POST-OP NONUNION AND BROKEN PLATE. THE FIRST SURGERY WAS OK AND THE EVOLUTION AT 1ST AND 2ND REVISION WAS SATISFACTORY (ONE AND THREE MONTHS). IT WAS IN THE 3RD REVISION WHEN THE NONUNION AND BROKEN PLATE WAS OBSERVED. MATERIAL IS COMING BACK THEREFORE REVISION SURGERY TOOK PLACE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861226 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 H/LT-STER PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 7624470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention