BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM TI MATRIX SCREW SELF-TAPPING/6MM

    MDR report key: 20919992 · Received December 12, 2024

    Report

    Report Number
    8030965-2024-14982
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 30, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    UDI-DI
    07611819358140
    PMA / PMN Number
    K083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED, THE PREVIOUSLY REPORTED EVENTS UNDER MRN 8030965-2024-14981, 8030965-2024-14980, 8030965-2024-14978, AND 8030965-2024-14982 ARE NO LONGER CONSIDERED REPORTABLE AT THIS TIME AS THERE WAS NO FAILURE OF THE DEVICE. NO FURTHER FOLLOW-UPS WILL BE SENT UNDER MRN 808030965-2024-14981, 8030965-2024-14980, 8030965-2024-14978, AND 8030965-2024-14982.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOAN SET ON BOOKING HAD 4MM SCREWS LABELLED AS 6MM SCREWS. THERE WERE APPROXIMATELY 6 SCREWS AFFECTED AND THIS RESULTED IN THE SURGEON NEEDING TO DEVIATE FROM THE PLANNED SCREW LENGTHS FOR THIS CASE. THERE WERE 6 X 04.511.204.01C SCREWS IN PLACE OF 6 X 04.511.206.01C SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417304 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM BONE PLATE JEY SYNTHES GMBH 07611819358140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown