BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: FNS

    MDR report key: 24183937 · Received January 26, 2026

    Report

    Report Number
    8030965-2026-00908
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    January 8, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. INVESTIGATION SUMMARY. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HALL T, BAKER M, PADKIN R. OUTCOMES OF FEMORAL NECK SYSTEM PROCEDURES IN A MAJOR TRAUMA CENTRE. CUREUS. 2026 JAN 8;18(1):E101113. DOI: 10.7759/CUREUS.101113. PMID: 41523729; PMCID: PMC12782779. OBJECTIVE/METHODS/STUDY DATA: THE FEMORAL NECK SYSTEM (FNS) WAS DEVELOPED TO PROVIDE MINIMALLY INVASIVE FIXATION WITH IMPROVED ROTATIONAL AND ANGULAR STABILITY, AIMING TO REDUCE AVN RISK; HOWEVER, CLINICALLY SIGNIFICANT COMPLICATIONS STILL OCCUR. HENCE, THIS STUDY AIMED TO ASSESS COMPLICATION AND REOPERATION RATES FOLLOWING FEMORAL NECK FRACTURE FIXATION USING FNS IN A MAJOR TRAUMA CENTRE, AND TO COMPARE THESE FINDINGS WITH PUBLISHED OUTCOMES AND ALTERNATIVE FIXATION STRATEGIES. BETWEEN 2019 AND 2024, A TOTAL OF 70 PATIENTS UNDERWENT FNS FIXATION FOR FEMORAL NECK FRACTURES. THREE WERE EXCLUDED (INCOMPLETE DATA), LEAVING 67 FOR ANALYSIS. THE MEAN AGE WAS 73.6 (SD = 11.2) YEARS (RANGE = 31-94), AND THE MALE-TO-FEMALE RATIO WAS 30:37. ALL PATIENTS RECEIVED RADIOGRAPHIC FOLLOW-UP FOR AT LEAST THREE MONTHS. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES FNS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FNS (QTY 2): 22.4% IS THE OVERALL COMPLICATION RATE; NO INTERVENTION WAS MENTIONED. AMONG PATIENTS WHO EXPERIENCED COMPLICATIONS 60% PATIENTS WERE ATTRIBUTABLE TO AVASCULAR NECROSIS (AVN) NO INTERVENTION WAS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241110 UNK - CONSTRUCTS: FNS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention