BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAILS: AFN

    MDR report key: 18236086 · Received November 30, 2023

    Report

    Report Number
    8030965-2023-14987
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 7, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D1, D2A, D2B, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN NAILS: AFN/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE EXTRACTION DEVICE FOR THE EXPERT AFN (ANTEGRADE FEMORAL NAIL). DURING SURGERY, IT WAS FOUND THAT THE EXTRACTION DEVICE WAS THE WRONG DEVICE. ALTHOUGH THE SURGEON MANAGED TO REMOVE THE LOCKING SCREW AND END CAP, THE NAIL COULD NOT BE REMOVED AND REMAINED IN THE BODY. THE SURGERY WAS EXTENDED FOR ABOUT AN HOUR DUE TO TIME SPENT LOOKING FOR A REPLACEMENT. ON (B)(6) 2023 THE REMOVAL SURGERY WOULD BE PERFORMED AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE UNK - NAILS: AFN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884993 UNK - NAILS: AFN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK - EXTRACTION INSTRUMENTS: TRAUMA