BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: FNS

    MDR report key: 23803202 · Received December 15, 2025

    Report

    Report Number
    8030965-2025-12511
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    February 1, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 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.

    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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: PARK JW, CHA YH, KIM JW, KIM HS, NHO JH, JANG BW, KIM JT, KIM JK, KIM TY, KIM KC, LEE YK. INABILITY TO REMOVE LOCKING SCREWS FROM THE FEMORAL NECK SYSTEM DUE TO STRIPPING OF THE SCREWDRIVER WITHIN THE LOCKING SCREW HEAD. J ORTHOP TRAUMA. 2025 FEB 1;39(2):63-67. DOI: 10.1097/BOT.0000000000002926. PMID: 39393062. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSES OF THIS STUDY WERE TO INVESTIGATE THE FREQUENCY OF SCREWDRIVER STRIPPING IN THE HEAD OF THE LOCKING SCREW THAT ATTACHES TO THE SIDE PLATE TO THE FEMUR SHAFT AMONG THE PATIENTS WHO UNDERWENT IMPLANT REMOVAL AFTER FEMORAL NECK SYSTEM (FNS) FOR FEMORAL NECK FRACTURE, TO DETERMINE THE RISK FACTORS FOR LOCKING HEAD SCREW STRIPPING IN FNS TREATMENT OF FEMORAL NECK FRACTURE, AND TO SUGGEST A SURGICAL TIP THAT REMOVES FNS, WHICH IS DIFFICULT TO REMOVE DUE TO SCREW STRIPPING. BETWEEN NOVEMBER 2019 AND FEBRUARY 2023 WERE REVIEWED, A TOTAL OF 47 PATIENTS UNDERWENT IMPLANT REMOVAL SURGERY OF FNS. THE ELECTRONIC MEDICAL RECORDS AND RADIOGRAPHS OF PATIENTS WHO UNDERWENT IMPLANT REMOVAL SURGERY AFTER INTERNAL FIXATION USING FNS DUE TO FEMORAL NECK FRACTURE. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. 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 37): -16 PATIENTS HAD REOPERATION DUE TO LOSS OF REDUCTION -7 PATIENTS HAD POST TRAUMATIC OSTEONECROSIS OF THE FEMORAL HEAD; NO INTERVENTION WAS MENTIONED. -1 PATIENT NEEDED TO REMOVE THE DEVICE DUE TO PERI-IMPLANT SUBTROCHANTERIC FRACTURE AFTER ADDITIONAL TRAUMA. -5 PATIENTS REQUESTED IMPLANT REMOVAL -8 PATIENTS UNDERWENT ARTHROPLASTY DUE TO COMPLICATIONS SUCH AS OSTEONECROSIS OF THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607985 UNK - CONSTRUCTS: FNS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention