BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: NAIL LOCKING

    MDR report key: 21515116 · Received March 4, 2025

    Report

    Report Number
    8030965-2025-02101
    Event Type
    Injury
    Date Received
    March 4, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. D6: DATE OF IMPLANTATION IS AN UNKNOWN DATE BETWEEN DECEMBER 2020 AND MARCH 2022.

    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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: VLASAK AL, PALM LS, HAGEN JE, PATRICK MR, PAZIKI MN, VLASAK, RG TALERICO, MT. INTERLOCKING SCREW BACKOUT FROM A PREASSEMBLED POLYMER INLAY IN A RETROGRADE FEMORAL NAIL SYSTEM: A RETROSPECTIVE REVIEW. ELECTRONIC COPY AVAILABLE AT: HTTPS://SSRN.COM/ABSTRACT=5105169. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO PRESENT A SINGLE INSTITUTION RETROSPECTIVE REVIEW OF PLACED RETROGRADE FEMORAL NAILS AND THEIR COMPLICATIONS, PARTICULARLY LOSS OF INTERLOCKING BOLT FIXATION AND REVISION SURGERY IN THE DEPUY SYNTHES RFN-A GROUP (21.43%), COMPARED TO OTHER IMPLANT DESIGNS (5.41%) DURING THE INITIAL IMPLEMENTATION PERIOD AT OUR INSTITUTION. BETWEEN DECEMBER 2020 AND MARCH 2022, A TOTAL OF 28 PATIENTS WITH A MEAN AGE OF 64.0 (18.9-91.5) TREATED WITH DEPUY SYNTHES RFN-ADVANCED RETROGRADE FEMORAL NAILING SYSTEM. THERE WAS NO MINIMUM FOLLOW-UP PERIOD REQUIRED FOR INCLUSION IN THE STUDY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES ADVANCED RETROGRADE FEMORAL NAILING SYSTEM (RFN-A). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) -PATIENT #1, FEMALE HAD INTERLOCKING SCREW BACK OUT WHICH REQUIRES HARDWARE REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) -PATIENT #2, MALE HAD INTERLOCKING SCREW BACK OUT WHICH WAS GIVEN AN APPROPRIATE ADMINISTRATION OF IV ANTIBIOTICS, IRRIGATION AND DEBRIDEMENT (I&D) AND REQUIRES ORIF WITH A 4-HOLE DYNAMIC SCREW. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) -PATIENT #3, MALE HAD INTERLOCKING SCREW BACK OUT WHICH ADDITIONALLY REQUIRES SCREW TRACT I&D WITH HARDWARE REMOVAL GIVEN AN INFECTED APPEARANCE AT THE SCREW BACK OUT SITE AND POSITIVE OR CULTURE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) -PATIENT #4, FEMALE HAD INTERLOCKING SCREW BACK OUT WHICH REQUIRES HARDWARE REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) -PATIENT #5, FEMALE HAD INTERLOCKING SCREW BACK OUT WHICH REQUIRES HARDWARE REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) -PATIENT #6, FEMALE HAD INTERLOCKING SCREW BACK OUT WHICH REQUIRES HARDWARE REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: NAIL LOCKING (QTY 1) -PATIENT #7, FEMALE HAD INTERLOCKING SCREW BACK OUT WHICH REQUIRES HARDWARE REMOVAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: RFNA (QTY 1) -PATIENT #2, MALE WHICH WAS GIVEN AN APPROPRIATE ADMINISTRATION OF IV ANTIBIOTICS, IRRIGATION AND DEBRIDEMENT (I&D) AND REQUIRES ORIF WITH A 4-HOLE DYNAMIC SCREW. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: RFNA (QTY 1) -PATIENT #3, MALE WHICH ADDITIONALLY REQUIRES SCREW TRACT I&D WITH HARDWARE REMOVAL GIVEN AN INFECTED APPEARANCE AT THE SCREW BACK OUT SITE AND POSITIVE OR CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635333 UNK - SCREWS: NAIL LOCKING SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention