BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: NAIL LOCKING

    MDR report key: 22679387 · Received July 31, 2025

    Report

    Report Number
    8030965-2025-07878
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 CITE HAS BEEN REVIEWED: MUSICK AN, WAGNER RK, KRAUS KM, SOUTHALL WGS, GREGG AT, POLICICCHIO TJ, MUHAMMAD M, DUNCAN ST, LANDY DC, ANEJA A. DISTAL INTERLOCKING SCREW BACKOUT IN NEW-GENERATION RETROGRADE FEMORAL NAILS. J ORTHOP TRAUMA. 2025 JUL 14. DOI: 10.1097/BOT.0000000000003043. EPUB AHEAD OF PRINT. PMID: 40657926. OBJECTIVE/METHODS/STUDY DATA :THE AIM OF THIS RETROSPECTIVE COMPARATIVE STUDY WAS TO COMPARE DISTAL INTERLOCKING SCREW BACKOUT RATES BETWEEN TWO NEW-GENERATION RETROGRADE FEMORAL NAILS: THE DEPUY SYNTHES RFN-ADVANCED RETROGRADE FEMORAL NAIL (RFNA) AND THE STRYKER T2 ALPHA FEMUR RETROGRADE NAIL (T2 ALPHA). BETWEEN NOVEMBER 2022 AND AUGUST 2024, A TOTAL OF 103 PATIENTS WERE INCLUDED IN THE STUDY. DIVIDED INTO TWO GROUPS RFNA ,CONSISTS OF 13 FEMALE AND 11 MALE WITH THE MEAN AGE OF 62 (RANGE OF 42-74) YEARS. TREATED WITH DEPUY SYNTHES RFN-ADVANCED RETROGRADE FEMORAL NAIL (RFNA) WHILE T2 ALPHA WITH 50 FEMALE AND 29 MALE WITH THE MEAN AGE 58(RANGE OF 36-73) YEARS TREATED WITH STRYKER T2 ALPHA FEMUR RETROGRADE NAILING SYSTEM. WITH A MINIMUM FOLLOW-UP OF 3 MONTHS. WITH A MINIMUM FOLLOW-UP OF 3 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES ADVANCED RETROGRADE FEMORAL NAIL (RFNA). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK -SCREWS: NAIL LOCKING (QTY 9). -9 PATIENTS (38%) WITH HIGHER RATE OF DISTAL INTERLOCKING SCREW BACKOUT; INTERVENTION: NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197557 UNK - SCREWS: NAIL LOCKING SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown