BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSE PATIENT SET FMS 24PK

    MDR report key: 22165538 · Received June 9, 2025

    Report

    Report Number
    1221934-2025-02093
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 24, 2025
    Report Date
    June 9, 2025
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705023233
    PMA / PMN Number
    K951843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. H11 ADDITIONAL NARRATIVE: THE COMPLAINT DEVICE WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (3010852), AND NO NON-CONFORMANCE WAS IDENTIFIED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. H11 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

    Description of Event or Problem · 0

    REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT WHILE USING THE INFLOW TUBING FMS VUE 24PK DEVICE AND REUSE PATIENT SET FMS 24PK DEVICE, THE ERROR CODE FC004 WAS DISPLAYED AT THE SYSTEM PURGE, INFERRING THAT THE PUMP HAD EXCESS PRESSURE SO THE IRRIGATION WAS STOPPED. ACCORDING TO THE REPORTER, IT WAS ATTEMPTED TO RESOLVE THE ISSUE BY STARTING SEVERAL TIMES REACHING THE POINT OF TURNING OFF AND TURNING ON AND INSTALLING THE TUBES AGAIN, WHICH DID NOT WORK. IT WAS REPORTED THE PUMP MANUAL WAS REFERENCED WHERE IT INDICATED THAT THE ERROR CORRESPONDED TO A DIFFERENCE IN THE PRESSURE READERS AND THE SUGGESTION TO FIX IT WAS TO TURN OFF THE PUMP AND REPORT IT IN THE COMPANY. IT WAS REPORTED THAT THE DOCTOR COULD NOT CONTINUE WAITING FOR THE PUMP ISSUE TO BE SOLVED SINCE THERE WAS A DELAY OF SEVERAL MINUTES AT THE START OF THE SURGICAL PROCEDURE, SO HE DECIDED TO PASS THE IRRIGATION SYSTEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401662 REUSE PATIENT SET FMS 24PK ARTHROSCOPE HRX DEPUY MITEK LLC US 3010852 10886705023233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown