BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAIL HEAD ELEM: TFNA LAG SCREW

    MDR report key: 24248940 · Received February 3, 2026

    Report

    Report Number
    8030965-2026-01160
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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: TAN YY, TUN MH, TAN K, WAN JJY, BOO HC, MOO IH, YEO AKS. EVALUATING POLYMETHYLMETHACRYLATE (PMMA) AUGMENTATION IN CEPHALOMEDULLARY NAIL FIXATION OF HIP FRACTURES: A STEP TOWARDS EVIDENCE-BASED PATIENT SELECTION CRITERIA. EUR J TRAUMA EMERG SURG. 2026 JAN 13;52(1):16. DOI: 10.1007/S00068-025-03063-7. PMID: 41528463. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO DETERMINE WHICH PATIENTS ARE MOST LIKELY TO BENEFIT FROM PMMA AUGMENTATION. BETWEEN (B)(6) 2019 AND (B)(6) 2022, A TOTAL OF 286 PATIENTS WITH INTERTROCHANTERIC (IT) HIP FRACTURES WHO UNDERWENT SHORT TFNA¿ NAILING WERE INCLUDED IN THE STUDY. ALL PATIENTS WERE TREATED USING THE DEPUY SYNTHES TFNA¿ CEPHALOMEDULLARY NAIL SYSTEM, WITH EITHER A HELICAL BLADE OR LAG SCREW FOR FEMORAL HEAD FIXATION, AND SOME RECEIVED PMMA CEMENT AUGMENTATION. THE MEDIAN LENGTH FOLLOW-UP OF 12 MONTHS (IQR 9¿19.8.8). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TROCHANTERIC FIXATION NAIL ADVANCED (TFNA¿) (HELICAL BLADE OR LAG SCREW FOR FEMORAL HEAD FIXATION). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (QTY (B)(4)): QTY (B)(4): 12 HAD IMPLANT CUT-OUT/CUT-THROUGH (COCT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEM: TFNA LAG SCREW (QTY (B)(4)): QTY (B)(4): 4 HAD IMPLANT CUT-OUT/CUT-THROUGH (COCT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306711 UNK - NAIL HEAD ELEM: TFNA LAG SCREW ROD, FIXATION, INTRMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown