BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA FENESTRATED HELICAL BLADE 80MM - STERILE

    MDR report key: 18050468 · Received November 1, 2023

    Report

    Report Number
    8030965-2023-13703
    Event Type
    Injury
    Date Received
    November 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1 INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. H3, H4, H6: MANUFACTURING LOCATION: ELMIRA / PACKAGED, STERILIZED AND RELEASED BY: MONUMENT. MANUFACTURING DATE: 29-NOV-2022. EXPIRATION DATE: 01-11-2032. PART NUMBER: 04.038.380S, TFNA FENESTRATED HELICAL BLADE 80MM -STERILE. LOT NUMBER: 2004P98 (STERILE). NOTE: HELICAL BLADE WAS MANUFACTURED BY ELMIRA; LOT NUMBERS 2692P70 QTY (B)(4) AND 2817P33 QTY (B)(4). PARTS WERE PACKAGED, STERILIZED AND RELEASED BY MONUMENT. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. THIS LOT MET ALL VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH TFNA. AFTER SURGERY, CUT-OUT WAS CONFIRMED. ACCORDING TO THE SURGEON, THERE WAS NO PARTICULAR PROBLEM WITH TFNA; HOWEVER, THE FEMORAL HEAD GRADUALLY ROTATED DUE TO POOR BONE QUALITY. A REVISION SURGERY WILL BE PERFORMED NEXT WEEK. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 80MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024853 TFNA FENESTRATED HELICAL BLADE 80MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 3127P39

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention