BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MULTILOC END CAP F/MULTILOC NAIL/2MM EXTENSION-STERILE

    MDR report key: 19554771 · Received June 17, 2024

    Report

    Report Number
    8030965-2024-07585
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 22, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819431270
    PMA / PMN Number
    K103002
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11: ADDITIONAL NARRATIVE: H3, H4, H6: PART 04.019.002S, LOT 9437P45: MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: FEBRUARY 19, 2024. EXPIRATION DATE: FEBRUARY 01, 2034. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE FINISHED LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    PRODUCT COMPLAINT (B)(4) 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. H11 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J SALES REPRESENTATIVE H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY TREATING THE HUMERUS. AFTER INSERTING THE MULTILOC NAIL AND SCREWS, THE SURGEON INSERTED THE END CAP (0 MM), BUT IT INSERTED AT AN ANGLE AND COULD NOT REACH TO THE OPTIMUM LOCATION. THE SURGEON TRIED REINSERTING IT SEVERAL TIMES BUT FAILED. THEREFORE, THE SURGEON INSERTED ANOTHER END CAP (2 MM), BUT IT WAS NOT ABLE TO BE INSERTED EITHER. THE PROCEDURE WAS COMPLETED WITHOUT END CAPS EVENTUALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651733 TI MULTILOC END CAP F/MULTILOC NAIL/2MM EXTENSION-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 9437P45 07611819431270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MULTILOC END CAP F/MULTILOC HN/PHN EXTEN.| UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW.| UNK - NAILS: MULTILOC HUMERAL.