BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH

    MDR report key: 17946955 · Received October 16, 2023

    Report

    Report Number
    8030965-2023-12976
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 25, 2023
    Report Date
    October 11, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWN
    UDI-DI
    07611819435056
    PMA / PMN Number
    EXEMPT
    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. E1: 12-1 (B)(6) KAWASAKI CITY, JAPAN, KANAGAWA 210-0013, JAPAN. E3: REPORTER IS A (B)(6) EMPLOYEE. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY FOR CLAVICLE SHAFT FRACTURE WITH COMPRESSION WIRE. THE COMPRESSION WIRE IN QUESTION WAS USED TO TEMPORARILY FIX THE PLATE. AFTER INSERTING THE SCREWS, THE SURGEON ATTEMPTED TO REMOVE THE COMPRESSION WIRE, IN QUESTION BUT THE WIRE BROKE AT THE BALL. FORTUNATELY, THE BROKEN PART WAS REMOVED WITH PLIERS. X-RAY TAKEN ON AN UNKNOWN DATE CONFIRMED THAT THERE ARE NO PIECES LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347444 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH INSTRUMENT, COMPRESSION HWN SYNTHES GMBH 07611819435056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - PLATES: TRAUMA.| UNK - SCREWS: TRAUMA.