BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLOW TUBING FMS VUE 24PK

    MDR report key: 15878140 · Received November 29, 2022

    Report

    Report Number
    1221934-2022-03776
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    May 3, 2022
    Report Date
    November 29, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705023066
    PMA / PMN Number
    K951843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SHOULD THE DEVICE EVER BE RECEIVED BACK IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (3001687), AND NO NON-CONFORMANCE WAS IDENTIFIED. AS PART OF DEPUY MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION OR THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (3002317), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 THE ARTHROSCOPY INPUT IS INSTALLED IN THE PUMP AND AT THE TIME OF STARTING THE IRRIGATION IT IS CAPPED AS WELL AS THE HOSES AND THE FILTER OF THIS INPUT FOR THIS REASON THE INPUT COULD NOT BE USED ANYMORE AND REPLACED. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES EIGHT (2) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947545 INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE HRX DEPUY MITEK LLC US 284508 3002317 10886705023066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown