BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: HUMERAL NAIL

    MDR report key: 14937656 · Received July 6, 2022

    Report

    Report Number
    8030965-2022-04591
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    October 20, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K: THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YU X, ET AL (2021), COMPARISON OF EXPANDABLE INTRAMEDULLARY NAIL AND LOCKING COMPRESSION PLATE IN THE TREATMENT OF HUMERAL SHAFT FRACTURE, CHINESE BOOK CLASSIFICATION NUMBER: R683. 41, ARTICLE NUMBER 1000-9736202112-1250-03, (CHINA). TO OBJECTIVE OF THE STUDY IS TO COMPARE THE EFFICACY AND SAFETY OF EXPANDABLE INTRAMEDULLARY NAIL (EIMN) AND LOCKING COMPRESSION PLATE IN THE TREATMENT OF HUMERAL SHAFT FRACTURES. FROM JANUARY 2020 TO JANUARY 2021, 90 PATIENTS WITH HUMERAL SHAFT FRACTURE WHO UNDERWENT FIXATION WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS, THE EXPANDABLE INTRAMEDULLARY NAIL (EIMN) GROUP (45 PATIENTS) AND THE CONTROL GROUP (45 PATIENTS). IN THE EIMN GROUP, THERE WERE 25 MALES AND 20 FEMALES WITH A MEAN AGE OF 36. 6 ± 12. 4 (RANGE 19 TO 58) YEARS. PATIENTS IN THE EIMN GROUP WERE IMPLANTED WITH AN UNKNOWN SYNTHES EXPANDABLE INTRAMEDULLARY NAIL. DURING THE PROCEDURE, AFTER THE APPROPRIATE LENGTH OF THE INTRAMEDULLARY NAIL, THE PRESSURE PUMP IS CONNECTED TO EXPAND THE INTRAMEDULLARY NAIL; FINALLY, THE PRESSURE PUMP IS REMOVED, AND THE END CAP IS INSTALLED. MEANWHILE IN THE CONTROL GROUP, THE PATIENTS WERE IMPLANTED WITH A COMPETITOR¿S LOCKING COMPRESSION PLATE. THE PATIENTS WERE FOLLOWED UP AT 3 AND 6 MONTHS AFTER OPERATION, AND THE SHOULDER AND ELBOW JOINT FUNCTION SCORES AND RECOVERY WERE COMPARED BETWEEN THE TWO GROUPS. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD DELAYED UNION. 1 PATIENT HAD RADIAL NERVE PALSY. THIS REPORT IS FOR THE UNKNOWN SYNTHES EXPANDABLE INTRAMEDULLARY NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047869 UNK - CONSTRUCTS: HUMERAL NAIL NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other