BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: FNS

    MDR report key: 23031629 · Received September 11, 2025

    Report

    Report Number
    8030965-2025-09242
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    January 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: CHEN P, XU H, ZHANG Y, HUANG H. OBSERVATION ON CURATIVE EFFECT OF FEMORAL NECK DYNAMIC CROSS SYSTEM AND HOLLOW SCREW IN TREATMENT OF FEMORAL NECK FRACTURE IN YOUNG ADULTS. DOI: 10.3969/J.ISSN .1009-7147.2024.07.013. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE CLINICAL EFFICACY OF FEMORAL NECK DYNAMIC CROSS SYSTEM (FNS) AND CANNULATED COMPRESSION SCREWS (CCS) IN THE TREATMENT OF FEMORAL NECK FRACTURE IN YOUNG ADULTS. BETWEEN DECEMBER 2019 AND JUNE 2022, A TOTAL OF 66 PATIENTS WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS. FNS GROUP CONSIST OF 30 PATIENTS (19 MALE AND 11 FEMALE) WITH A MEAN AGE OF (32 ± 5), RANGE 18 TO 56 YEARS TREATED WITH FEMORAL NECK DYNAMIC CROSS SYSTEM WHILE CCS GROUP CONSIST OF 36 PATIENTS (22 MALE AND 14 FEMALE) WITH A MEAN AGE OF (30 ± 4), RANGE 18 TO 55 YEARS TREATED WITH CANNULATED COMPRESSION SCREWS. ALL INCLUDED SUBJECTS WERE FOLLOWED UP FOR 12 TO 24 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES FEMORAL NECK DYNAMIC CROSS SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FNS (QTY 6). 2 PATIENTS HAD NONUNION. NO INTERVENTION MENTIONED. 2 PATIENTS HAD FEMORAL HEAD NECROSIS. NO INTERVENTION MENTIONED. 2 PATIENTS HAD FEMORAL NECK SHORTENING. NO INTERVENTION MENTIONED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FNS (QTY 1). A 57-YEAR-OLD WOMAN WITH FEMORAL NECK FRACTURE TREATED WITH FNS SURGERY HAD NONUNION AND RADIOGRAPHIC DATA OF FEMORAL HEAD NECROSIS 1.5 YEARS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2708589 UNK - CONSTRUCTS: FNS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention