BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAIL HEAD ELEMENTS: FNS BOLT

    MDR report key: 23820620 · Received December 16, 2025

    Report

    Report Number
    8030965-2025-12640
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    January 29, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: ADDED: D4 (CATALOG), E1 (FACILITY NAME). H3, 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIN Y, ZHOU X, LI Z, LIU Y, XU R, SHEN J, ZHANG X, YU X. THE EFFECTS OF THE POSITIONING OF A BOLT IN THE FEMORAL NECK SYSTEM ON THE SHORT-TERM OUTCOMES OF MIDDLE-AGED AND YOUNG ADULTS WITH DISPLACED FEMORAL NECK FRACTURES. BMC MUSCULOSKELET DISORD. 2025 JAN 29;26(1):91. DOI: 10.1186/S12891-025-08349-W. PMID: 39881279; PMCID: PMC11776276. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ANALYZE THE EFFECTS OF THE POSITIONING OF A BOLT IN THE FEMORAL NECK SYSTEM (FNS) ON THE SHORT-TERM OUTCOMES OF MIDDLE-AGED AND YOUNG ADULTS WITH DISPLACED FEMORAL NECK FRACTURES (FNFS). BETWEEN DECMEBER 2019 AND JANUARY 2023, A TOTAL OF 114 PATIENTS WHO WERE SURGICALLY TREATED WITH INTERNAL FIXATION USING THE FNS (DEPUY SYNTHES, SWITZERLAND) WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO CENTRAL GROUP (W=20%, N=63) AND A DEVIATION GROUP (W>20%, N=51) ON THE BASIS OF THE CT-MEASURED W ON THE 2ND POSTOPERATIVE DAY. THE CENTRAL GROUP CONSISTED OF 27 MALE AND 36 FEMALE PATIENTS WITH A MEAN AGE OF 46.41±8.03 YEARS. THE DEVIATION GROUP WAS COMPOSED OF 20 MALE AND 31 FEMALE PATIENTS WITH A MEAN AGE OF 45.14±9.80 YEARS. POSTOPERATIVE FOLLOW-UP WAS PERFORMED AT 1, 3, 6 AND 12 MONTHS IN THE OUTPATIENT DEPARTMENT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES FNS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: FNS (QTY 23): AN UNKNOWN NUMBER OF PATIENT HAD FEMORAL NECK SHORTENING; INTERVENTION NOT REPORTED. (N=13) EARLY COMPLICATIONS (NOT SPECIFIED FROM THE FOLLOWING: E.G., POOR WOUND HEALING, WOUND INFECTION, ABNORMAL SENSATION OF THE SKIN AROUND THE SURGICAL INCISIONS, PULMONARY INFECTION, DVT). (N=4) POSTOPERATIVE AVASCULAR NECROSIS OF THE FEMORAL HEAD (ANFH) WHICH WAS MANAGED WITH REVISION TOTAL HIP REPLACEMENT. (N=5) UNDERWENT REVISION SURGERY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - NAIL HEAD ELEMENTS: FNS BOLT (QTY 52): (N=1) CUT-OUT FAILURE WAS REPORTED; INTERVENTION NOT REPORTED. (N=51) DEVIATION GROUP - HAD A DEGREE OF DEVIATION OF THE CENTRAL AXIS OF THE FEMORAL HEAD AND NECK FROM THE TIP OF THE BOLT (W), WITH AN AVERAGE W (%) OF 28.55%±6.42%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140355 UNK - NAIL HEAD ELEMENTS: FNS BOLT APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown