BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: DHS/DCS

    MDR report key: 25016970 · Received April 28, 2026

    Report

    Report Number
    8030965-2026-03910
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    December 8, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHOU KC, LEE KH, CHEN CM, LIN YK, WU PK, CHEN CF, CHEN WM. COMPARISON OF TREATMENT OPTIONS WITH LONG INTRAMEDULLARY NAIL AND DYNAMIC HIP SCREWS FOR METASTATIC SUBTROCHANTERIC FRACTURE: A COHORT STUDY. J CHIN MED ASSOC. 2026 JAN 1;89(1):76-84. DOI: 10.1097/JCMA.0000000000001322. EPUB 2025 DEC 8. PMID: 41355456; PMCID: PMC12815553. OBJECTIVE/METHODS/STUDY DATA: IN THE PRESENT STUDY, THE OUTCOMES OF DYNAMIC HIP SCREW (DHS) AND INTRAMEDULLARY NAIL (IMN) FIXATION FOR METASTATIC SUBTROCHANTERIC FRACTURES WERE COMPARED FOCUSING ON LOCAL TUMOR PROGRESSION, DISTAL CANAL SEEDING, IMPLANT SURVIVAL, AND THE SUBSEQUENT NEED FOR REVISION SURGERY. BETWEEN JANUARY 2002 AND DECEMBER 2018, 239 PATIENTS WITH PROXIMAL FEMORAL METASTATIC LESIONS WERE TREATED AT OUR INSTITUTION. AFTER EXCLUDING 149 CASES INVOLVING FEMORAL HEAD, NECK, OR INTERTROCHANTERIC METASTASIS, ENDOPROSTHETIC RECONSTRUCTION, OR CONSERVATIVE MANAGEMENT, 90 PATIENTS WITH SUBTROCHANTERIC PATHOLOGICAL FRACTURES TREATED WITH INTERNAL FIXATION WERE ELIGIBLE FOR ANALYSIS. OF THESE, 48 UNDERWENT IMN FIXATION AND 42 UNDERWENT DHS FIXATION. THE MEAN AGE OF THE IMN AND DHS GROUPS WAS NEARLY IDENTICAL (64.2 VS 64.2 YEARS; P = 0.945). THE SEX DISTRIBUTION WAS SIMILAR, WITH 26 WOMEN AND 22 MEN IN THE IMN GROUP AND 25 WOMEN AND 17 MEN IN THE DHS GROUP (P = 0.673). IN THE IMN COHORT, EACH PATIENT UNDERWENT INTRALESIONAL CURETTAGE, FOLLOWED BY FIXATION WITH ONE OF THE FOLLOWING SYSTEMS: PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA; DEPUY SYNTHES, RAYNHAM, MA, USA; N = 4), CEPHALOMEDULLARY NAIL (ZIMMER BIOMET, WARSAW, IN, USA; N = 7), OR GAMMA-3 NAIL (STRYKER, MAHWAH, NJ, USA; N = 37). IN THE DHS COHORT, STABILIZATION WAS ACHIEVED USING A DYNAMIC HIP SCREW SYSTEM (DEPUY SYNTHES, RAYNHAM, MASSACHUSETTS, USA). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES DYNAMIC HIP SCREW SYSTEM. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: CEMENT (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: DHS/DCS (QTY 14): (N=1) PERIPROSTHETIC FRACTURE; NO TREATMENT REPORTED. (N=2) LOCAL PROGRESSION OF TUMORS; NO TREATMENT REPORTED. (N=2) UNDERWENT ENDOPROSTHESIS REPLACEMENT. (N=7) UNDERWENT REVISION OPEN REDUCTION AND INTERNAL FIXATION (ORIF). (N=2) INFECTION; NO TREATMENT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: DHS/DCS (QTY 7): (N=7) IMPLANT BREAKAGE; NO TREATMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626467 UNK - SCREWS: DHS/DCS APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown