BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN-LOCKSCR ø5 L25 TAN

    MDR report key: 17169610 · Received June 21, 2023

    Report

    Report Number
    8030965-2023-07720
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 31, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    10886982116314
    PMA / PMN Number
    K023802
    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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. 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 LOT: PART:04.205.025S; LOT:9L29987; MANUFACTURING SITE: WERK SELZACH; SUPPLIER:FRÜH VERPACKUNGSTECHNIK AG; RELEASE TO WAREHOUSE DATE:27 APR 2022; EXPIRATION DATE: 01 APR 2032. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 04.205.025; NON-STERILE LOT # 684P200; MANUFACTURING SITE: WERK SELZACH; SUPPLIER: SYNTHES USA HQ, INC; RELEASE TO WAREHOUSE DATE:10 MAR 2022. 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 DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER SURGERY THE INFECTION WAS FOUND, AND THE PATIENT WAS STARTED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN ORIF SURGERY FOR PLATEAU FRACTURE OF PROXIMAL LEFT TIBIA ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. INFECTION WAS SEEN ON THE LATERAL AND MEDIAL SIDES OF THE PROXIMAL TIBIA. THE PATIENT WILL BE MONITORED WITH ANTIBIOTICS TO PRIORITIZE BONE-UNION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0MM TI CANNULATED LOCKING SCREW 25MM. THIS IS REPORT 2 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215520 CANN-LOCKSCR ø5 L25 TAN PLATE, FIXATION, BONE HRS SYNTHES GMBH 04.205.025 9L29987 10886982116314

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention CANN-LOCKSCR ø5 L25 TAN.| CANN-LOCKSCR ø5 L80 TAN.| CANN-LOCKSCR ø5 L80 TAN.| CANN-LOCKSCR ø5 L80 TAN.| CORTSCR Ø4.5 SELF-TAP L32 TI.| CORTSCR Ø4.5 SELF-TAP L46 TI.| LCP PROXIMAL TIBIAL PL 4.5/5 LAT LE SHAF.| LCP-T-PL-4.5/5 SHAFT 4HO L83 TI.| LOCKSCR Ø5 SELF-TAP L32 TAN.| LOCKSCR Ø5 SELF-TAP L34 TAN.| LOCKSCR Ø5 SELF-TAP L34 TAN.