BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: AFN

    MDR report key: 11436221 · Received March 8, 2021

    Report

    Report Number
    8030965-2021-01710
    Event Type
    Injury
    Date Received
    March 8, 2021
    Report Date
    February 11, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: AFN UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN. UDI NUMBER IS UNKNOWN. 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). 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 REPORTS AN EVENT IN TAIWAN AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YANG, T.C. ET AL (2021), ¿RATIO OF FRACTURE SITE DIAMETER TO ISTHMUS FEMORAL CANAL DIAMETER¿AS A PREDICTOR OF COMPLICATION FOLLOWING TREATMENT OF INFRA-ISTHMAL FEMORAL SHAFT FRACTURE WITH ANTEGRADE INTRAMEDULLARY NAILING, INJURY, VOL. XX (XX), PAGES 1-6 (TAIWAN). THE AIM OF THIS RETROSPECTIVE STUDY IS TO ANALYSE THE FI RATIO AS A PREDICTIVE FACTOR FOR OCCURRENCE OF COMPLICATION, INCLUDING NON-UNION, MAL-ALIGNMENT, OR FIXATION FAILURE, FOLLOWING TREATMENT OF INFRA-ISTHMAL FEMORAL SHAFT FRACTURES USING ANTEGRADE IM NAILING. BETWEEN JANUARY 2008 TO DECEMBER 2018, A TOTAL 65 PATIENTS (41 MALE AND 24 FEMALE) WITH A MEAN AGE OF 47.1±21.9 (RANGE, 20 TO 91) YEARS UNDERWENT CLOSED REDUCTION AND INTERNAL FIXATION WITH ANTEGRADE IM NAILING. SURGERY WAS PERFORMED USING EXPERT ANTEGRADE FEMORAL NAIL (DEPUY SYNTHES, OBERDORF, SWITZERLAND), SIMPLIFIED UNIVERSAL NAIL (DEPUY SYNTHES, OBERDORF, SWITZERLAND), AND COMPETITOR DEVICE. ALL PATIENT HAD A MINIMUM OF 1-YEAR FOLLOW-UP. THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD MALE PATIENT SHOWED AT 6-MONTH RADIOGRAPH WITH PROGRESSIVE ANGULATION. 7 PATIENTS HAD A MALALIGNMENT. 4 PATIENTS HAD A PROGRESSIVE LOSS OF REDUCTION. 3 PATIENTS HAD NONUNION AND UNDERWENT REOPERATION. 4 PATIENTS HAD A FIXATION FAILURE AND UNDERWENT REOPERATION. THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: AFN. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332669 UNK - CONSTRUCTS: AFN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention