BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE

    MDR report key: 10395548 · Received August 12, 2020

    Report

    Report Number
    8030965-2020-05884
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 21, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819501102
    PMA / PMN Number
    K120807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. H3, H6: PART NUMBER: 04.016.225S, LOT NUMBER: 6L08779, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 15 NOV 2019, EXPIRY DATE:01 NOV 2029. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR DEVICE LOT NUMBER, AND NO NON-CONFORMANCES POTENTIALLY RELATED TO THE ISSUE WERE IDENTIFIED (NR-0132795 REFERRED ON THE HEADER OF SYNTHES LOT DHR IS THE PLANNED DOCUMENTAL NON-CONFORMANCE WHICH HAS BEEN PROCESSED TO MIGRATE THE WIP WORKORDERS FROM J&J TO JABIL DURING THE COMPANY TRANSFER). 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.

    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. 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 · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4). 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE ORIF SURGERY FOR PROXIMAL HUMERAL FRACTURES BY USING THE MULTILOC HUMERAL NAIL SYSTEM. THE OPERATION WAS PERFORMED ACCORDING TO THE USUAL PROCEDURES. WHEN THE SURGEON MADE AN INCISION IN ORDER TO INSERT A SCREW AT THE DISTAL END, HE INJURED THE BRACHIAL ARTERY OF THE PATIENT. FIRST, HE PUT A CLIP ON THE BLOOD VESSEL AND THEN INSERTED TWO SCREWS LATERALLY AND SUTURED THE BRACHIAL ARTERY. THE SURGERY WAS COMPLETED WITH A 120-MINUTE SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREWDRIVER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860780 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB OBERDORF SYNTHES PRODUKTIONS GMBH 6L08779 07611819501102

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention UNK - SCREWDRIVERS| UNK - SCREWS: TRAUMA| UNK - SCREWDRIVERS| UNK - SCREWS: TRAUMA