BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI HDLSS COMPRESSION SCR 10MM/SHORT THREAD-STERILE

    MDR report key: 18067383 · Received November 3, 2023

    Report

    Report Number
    8030965-2023-13885
    Event Type
    Injury
    Date Received
    November 3, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819972766
    PMA / PMN Number
    K161616
    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. B3: ONLY THE EVENT YEAR IS KNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, 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. DEVICE HISTORY REVIEW (DHR): PART # 04.226.210S. LOT # 9022561. MANUFACTURING SITE: WERK SELZACH LOGISTIK. RELEASE TO WAREHOUSE DATE: 10 JUN 2014. EXPIRATION DATE: 01 JUN 2024. SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 04.226.210. NON-STERILE LOT # 9014777. MANUFACTURING SITE: WERK GRENCHEN. RELEASE TO WAREHOUSE DATE: 04 JUN 2014. SUPPLIER: NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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.

    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 THE PRIMARY SURGERY WITH THE HCS (HEADLESS COMPRESSION SCREW) FOR THE MIDDLE PHALANX OF MIDDLE FINGER. AFTER SURGERY, DEHISCENCE OF THE FRACTURE WAS CONFIRMED. ONE OF THE TWO SCREWS WAS LOOSENED, AND A FRACTURE LIEN WAS CONFIRMED NEAR THE SCREW IN QUESTION. DURING THE PRIMARY SURGERY, THE SURGEON HAD NO CHOICE BUT TO INSERT THE SCREW DIAGONALLY TO THE FRACTURE LINE TO AVOID THE EXTENSOR TENDON. SINCE THE SCREW HEAD WAS TOO LARGE IN RELATION TO THE BONE AND DID NOT EMBED IN THE CORTEX, FIXATION WAS COMPLETED IN THAT STATE. NO PRESSURE WAS APPLIED TO THE FRACTURE, AND TWO HCS WERE INSERTED AS POSITIONING SCREWS. ALTHOUGH THERE WERE CONCERNS ABOUT STRENGTH OF FIXATION, THE SURGEON DECIDED TO COMPLETE THE SURGERY. POSTOPERATIVELY, SPLIT FIXATION WAS PERFORMED, AND THE PATIENT WAS CAUTIONED TO BE CAREFUL ABOUT THE STABILITY DURING REHABILITATION AND DAILY LIFE. THE PATIENT IS A TRUCK DRIVER AND RESUMED WORK THE DAY AFTER THE SURGERY. THE PATIENT¿S POST-OPERATIVE COMPLIANCE WAS POOR, AND THE FRACTURE WAS HITTING VARIOUS PLACES. THE REHABILITATION WAS ALSO EXCESSIVE. ON (B)(6) 2023, A REVISION SURGERY WILL BE PERFORMED. AFTER THE HCS IS REMOVED, A NEW HCS WILL BE INSERTED AGAIN. EXTERNAL FIXATION IS PREPARED FOR BACKUP. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE THIS REPORT INVOLVES ONE 2.4MM TI HDLSS COMPRESSION SCR 10MM/SHORT THREAD-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221607 2.4MM TI HDLSS COMPRESSION SCR 10MM/SHORT THREAD-STERILE SCREW, FIXATION, BONE HWC SYNTHES GMBH 9022561 07611819972766

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention HCS Ø2.4 SELF-DRILL CANN L14/4 TAN