BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE FEM NAIL ADVANCED Ø12 L280 5°

    MDR report key: 18767304 · Received February 23, 2024

    Report

    Report Number
    8030965-2024-02804
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 9, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07612334211262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H4, H6: MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 11-JAN-2022, EXPIRATION DATE: UNKNOWN, PART NUMBER: 04.233.228S, 12MM/RFN/280MM/ 5ANG/STER/POLY INLAY, LOT NUMBER: 457P161 (STERILE). PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, RFN ASSEMBLY INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PARTS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿NAIL STICKING OUT OF BONE¿ DOES NOT INDICATE BREAKAGE OF THE NAIL OR ANY OF ITS COMPONENTS. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. D2B: ADDITIONAL PRODUCT CODE: HSB D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE FEMALE PATIENT UNDERWENT ORIF FOR FEMORAL SHAFT FRACTURE. DURING THE SURGERY, A NAIL OF 12MM280MM CONCERNED WAS USED AND MOVED TO PROXIMAL AREA AFTER DISTAL FIXATION PHASE, THE NAIL WAS FOUND TO BE STICKING OUT OF HER BONE. ONE OF 11MM300MM WAS USED INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ADDITIONAL 45 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) RETROGRADE FEM NAIL ADVANCED Ø12 L280 5° THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125595 RETROGRADE FEM NAIL ADVANCED Ø12 L280 5° SCREW, FIXATION, BONE HWC SYNTHES GMBH 457P161 07612334211262

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female