BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP DORS-DRP-T2.4 SHAFT 5HO HE 3HO L5

    MDR report key: 20181357 · Received September 10, 2024

    Report

    Report Number
    8030965-2024-11063
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819433304
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. 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

    IT WAS REPORTED DURING INSPECTION ON AUGUST 19, 2024 SEVERAL PLATES WERE NOTED AS OLD AND APPEAR TARNISHED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE 2.4MM VA-LCP DORSAL DISTAL RAD T-PLATE/3H HD/3H SHAFT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296960 VA-LCP DORS-DRP-T2.4 SHAFT 5HO HE 3HO L5 PLATE, FIXATION, BONE HRS SYNTHES GMBH 07611819433304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown