BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TFN

    MDR report key: 9603564 · Received January 17, 2020

    Report

    Report Number
    2939274-2020-00277
    Event Type
    Injury
    Date Received
    January 17, 2020
    Report Date
    December 24, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: TFN/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN 2012 AND 2016. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/ OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GAUSDEN EB, ET AL. (2018), GAIT ANALYSIS AFTER INTERTROCHANTERIC HIP FRACTURE: DOES SHORTENING RESULT IN GAIT IMPAIRMENT ? J ORTHOP TRAUMA, VOLUME 32, NUMBER 11, PAGE 554-558, (USA). THE OBJECTIVE OF THIS STUDY WAS TO DETERMINE THE ASSOCIATION BETWEEN FRACTURE COLLAPSE WITH ALTERED GAIT AFTER INTERTROCHANTERIC FRACTURES TREATED WITH THE TROCHANTERIC FIXATION NAIL USING THE HELICAL BLADE. BETWEEN 2012 AND 2016, 72 PATIENTS WITH INTERTROCHANTERIC HIP FRACTURES (OTA/AO 31) TREATED WITH AN UNKNOWN SYNTHES TROCHANTERIC FIXATION NAIL SYSTEM USING THE HELICAL BLADE, WERE INCLUDED IN THE STUDY. THERE WERE 13 MEN AND 59 WOMEN WITH AN AVERAGE AGE OF 79.7 YEARS, RANGE 51-94 YEARS. AT FOLLOW-UP APPOINTMENTS, PATIENTS¿ GAIT PARAMETERS WERE RECORDED WHILE AMBULATING USING THE INTELLIGENT DEVICE FOR ENERGY EXPENDITURE AND ACTIVITY (IDEEA) SYSTEM TO PROVIDE TEMPOROSPATIAL GAIT ANALYSIS, INCLUDING CADENCE AND TIME SPENT IN DOUBLE STANCE PHASE. ALL PATIENTS HAD RADIOGRAPHS TAKEN AT THE TIME OF EACH GAIT ANALYSIS. THE MEAN LENGTH OF FOLLOW-UP BETWEEN THE SURGERY AND THE GAIT ANALYSIS WAS 8.6 MONTHS (60.7 MONTHS) WITH A MINIMUM OF 6 WEEKS. COMPLICATIONS WERE REPORTED AS FOLLOWS: 18 PATIENTS HAD A SHORTENING OF LESS THAN 1 MM ALONG THE HELICAL BLADE. 15 PATIENTS HAD A SHORTENING OF MORE THAN 8 MM ALONG THE HELICAL BLADE. 7 PATIENTS HAD A SHORTENING OF 10 MM OR MORE ALONG THE HELICAL BLADE. 2 PATIENTS HAD A SHORTENING OF MORE THAN 20 MM ALONG THE HELICAL BLADE. AN (B)(6) YEAR-OLD WOMAN HAD OVER 1.0 CM OF SHORTENING ACROSS THE HELICAL BLADE OF THE INTRAMEDULLARY NAIL NOTED DURING THE 3-MONTH FOLLOW-UP. THIS REPORT IS FOR THE UNKNOWN SYNTHES TROCHANTERIC FIXATION NAIL SYSTEM. THIS REPORT IS FOR ONE UNKNOWN CONSTRUCTS: TFN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63328 UNK - CONSTRUCTS: TFN OBERDORF SYNTHES PRODUKTIONS GMBH HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention