BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFNA

    MDR report key: 11391980 · Received March 1, 2021

    Report

    Report Number
    8030965-2021-01458
    Event Type
    Injury
    Date Received
    March 1, 2021
    Report Date
    February 5, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PFNA/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. 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 REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: QIU S., MA T., LIU H., WAN J., (2020)TIMING OF TRANEXAMIC ACID ADMINISTRATION IN ELDERLY PATIENTS WITH INTERTROCHANTERIC FRACTURE,INTERNATIONAL JOURNAL OF CLINICAL EXPERIMENTAL MEDICINE, VOLUME 13(10), PAGES 7709-7717 (CHINA). THIS STUDY AIMS TO EXPLORE THE SAFETY AND EFFECTS OF TRANEXAMIC ACID ADMINISTRATION AT DIFFERENT TIME POINTS ON THE BLOOD LOSS IN THE PERIOPERATIVE PERIOD OF ELDERLY PATIENTS WITH INTERTROCHANTERIC FRACTURE TREATED WITH PFNA. FROM JANUARY 2016 TO APRIL 2018, A TOTAL OF 120 ELDERLY PATIENTS WITH INTERTROCHANTERIC FRACTURE WERE ADMITTED AND WERE INCLUDED IN THE STUDY. PATIENTS WERE DIVIDED INTO GROUP A (GA, N=40) WITH 21 MALES, 19 FEMALES) AGE 68.24±7.25 YEAR GROUP B (GB, N=40) WITH 24 MALES, 16 FEMALES AGE 67.43±5.21 YEARS AND CONTROL GROUP (CG, N=40) WITH 22 MALES AND 18 FEMALES AGE 66.94±5.79 YEAR. ALL PATIENTS WERE TREATED WITH PFNA. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: 3 LIMB SWELLING, 2 INTRAMUSCULAR VEIN THROMBOSIS, 2 INCISION FAT LIQUEFACTION. GROUP B: 1 LIMB SWELLING, 2 INTRAMUSCULAR VEIN THROMBOSIS, 1 INCISION FAT LIQUEFACTION, CONTROL GROUP: 3 LIMB SWELLING, 1 INTRAMUSCULAR VEIN THROMBOSIS, 1 INCISION FAT LIQUEFACTION. THIS REPORT IS FOR AN UNKNOWN SYNTHES PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292703 UNK - CONSTRUCTS: PFNA ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention