BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: FNS LOCKING

    MDR report key: 25067811 · Received May 4, 2026

    Report

    Report Number
    8030965-2026-04176
    Event Type
    Injury
    Date Received
    May 4, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (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: GENGATHARAN D, ZI XIAN JC, XUANRONG MS, TZONG-YEE CW, WONG MK. FIXATION FAILURE FOLLOWING FEMORAL NECK SYSTEM FIXATION FOR INTRACAPSULAR FEMORAL NECK FRACTURES: ASSOCIATION WITH FRACTURE ORIENTATION. INJURY. 2026 APR 15;57(6):113280. DOI: 10.1016/J.INJURY.2026.113280. EPUB AHEAD OF PRINT. PMID: 41997098. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO EVALUATE FIXATION FAILURE FOLLOWING FNS FIXATION FOR INTRACAPSULAR FEMORAL NECK FRACTURES AND TO DETERMINE WHETHER FRACTURE-RELATED CHARACTERISTICS, PARTICULARLY FRACTURE ORIENTATION, WERE ASSOCIATED WITH FIXATION FAILURE. A RETROSPECTIVE COHORT STUDY WAS CONDUCTED TO EVALUATE FIXATION FAILURE FOLLOWING INTERNAL FIXATION OF INTRACAPSULAR FNFS USING THE FNS. PATIENTS WERE INCLUDED IF THEY MET THE FOLLOWING CRITERIA: 1. AGE = 18 YEARS, 2. INTRACAPSULAR FNF, 3. TREATMENT WITH THE FNS, 4. MINIMUM RADIOGRAPHIC FOLLOW-UP OF 12 MONTHS, OR EARLIER FIXATION FAILURE BEFORE 12 MONTHS. FIXATION WAS PERFORMED USING THE FEMORAL NECK SYSTEM (DEPUY SYNTHES, OBERDORF, SWITZERLAND). A TOTAL OF 82 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS. THE MEAN AGE OF THE COHORT WAS 70.1 ± 12.7 YEARS (RANGE, 41¿94 YEARS). OVERALL, 49 PATIENTS (59.8%) WERE FEMALE, AND 33 PATIENTS (40.2%) WERE MALE. THE MEAN DURATION OF FOLLOW-UP WAS 22.2 ± 10.2 MONTHS (RANGE, 2¿60 MONTHS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES FNS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FNS (QTY 8): -(N=4) NON-UNION; NO TREATMENT REPORTED. -(N=3) AVASCULAR NECROSIS OF THE FEMORAL HEAD; NO TREATMENT REPORTED. -(N=1) VARUS COLLAPSE; UNDERWENT SUBSEQUENT REVISION SURGERY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: FNS LOCKING (QTY 1): -(N=1) IMPLANT-RELATED MECHANICAL FAILURE, SPECIFICALLY BREAKAGE OF THE DISTAL LOCKING SCREW; UNDERWENT SUBSEQUENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323872 UNK - SCREWS: FNS LOCKING APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1