BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMA SYRING KIT 4*1 ML 2*2 ML

    MDR report key: 15382226 · Received September 8, 2022

    Report

    Report Number
    8030965-2022-06559
    Event Type
    Injury
    Date Received
    September 8, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    KIH
    UDI-DI
    07611819476523
    PMA / PMN Number
    EXEMPT
    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. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER NAME AND ADDRESS: (B)(6). INITIAL REPORTER OCCUPATION: REPORTER IS A J&J SALES REPRESENTATIVE. POSTAL CODE (B)(4). 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 UNKNOWN DATE, THE PATIENT UNDERWENT THE INITIAL SURGERY. AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT THE 1ST REVISION SURGERY WITH TFNA IMPLANTS AND CEMENT FOR UNKNOWN REASON ON (B)(6) 2021. BOTH THE INITIAL SURGERY AND THE 1ST REVISION SURGERY WERE PERFORMED AT ANOTHER HOSPITAL. IT IS NOT REPORTED THAT THE IMPLANTS USED IN THE INITIAL SURGERY WERE OUR COMPANY¿S PRODUCTS. AFTER THE 1ST REVISION SURGERY ON (B)(6) 2021, IT WAS FOUND THAT NON-UNION OCCURRED AND IT LED TO SHORTENING OF SHAFT. IN ADDITION, THE PROXIMAL BONE FRAGMENT OF THE BONE HEAD CUT OUT AND THE HELICAL BLADE PIERCED THE ACETABULUM. ON (B)(6) 2022, THE 2ND REVISION SURGERY WAS PERFORMED BECAUSE INFECTION ALSO HAD OCCURRED PARTIALLY. IN THE 2ND REVISION SURGERY, TFNA IMPLANTS WERE REMOVED, AND CEMENT BEADS WERE PLACED FOR THE TIME BEING. THE 2ND REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE 3RD REVISION SURGERY VIA THA WILL BE PERFORMED IN THE FUTURE. THE SURGEON STATED THAT IN THE 1ST REVISION SURGERY, THE AFFECTED AREA SEEMED TO BE FIXED WITH TFNA IMPLANTS WITH THE BONES REMAINED DISPLACED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)TRAUMA SYRING KIT 4*1 ML 2*2 ML. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235740 TRAUMA SYRING KIT 4*1 ML 2*2 ML DISPENSER, CEMENT KIH SYNTHES GMBH 07611819476523

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention