BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K C-MNT SCP,4.0,30,167,MITEK

    MDR report key: 19725847 · Received July 11, 2024

    Report

    Report Number
    1221934-2024-02413
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 11, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HRX
    UDI-DI
    10886705032075
    PMA / PMN Number
    K080560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 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. 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. D10: CONCOMITANT DEVICE: 4K C-MNT SCP,4.0,30,167,MITEK, THERAPY DATE; (B)(6) 2024 UDI: (B)(4)

    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. D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    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. H11 ADDITIONAL NARRATIVE: THE COMPLAINT DEVICE WAS RECEIVED AT THE MANUFACTURING SITE AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: - OUTER TUBE DAMAGED, DISTAL TIP DAMAGED - ILLUMINATION DISTAL TIP FIBER DAMAGED DEEP FIBER DAMAGED - PARTICULATE, OPTICS PARTICULATE UNDER DISTAL LENS - OPTICAL SYSTEM, OPTICAL COMPONENTS BROKEN LENSES IN OPTICAL SYSTEM DISTAL COVER GLASS/NEGATIVE DAMAGED SCRATCHED/RESIDUE/CRACKED - COSMETIC ISSUE SCRATCHES/DENTS DEPOSITS ON EXTERNAL OPTICAL SURFACES FUNCTIONAL : DAMAGED CONNECTOR, BROKEN (2+ PIECES) : DEVICE FRACTURED, VISUAL : SCRATCHED/NICKED PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. THE DEFECTIVE PARTS NEEDS TO BE REPLACED TO RESOLVE THE ISSUES. THE FAULTY PARTS WAS IDENTIFIED AS THE ROOT CAUSE FOR THE DEVICE FAILURE DURING THE SERVICE EVALUATION. 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. DEVICE HISTORY REVIEW ==> MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS AND/OR THE POTENTIAL CAUSE OF THE DEFECT CANNOT BE ASSOCIATED TO MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT DURING TESTING ON 7/1/2024 THE 2X 4K C-MNT SCP,4.0,30,167,MITEK DEVICE SCOPES WERE SCRATCHED AND IMAGES ARE BLURRY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289511 4K C-MNT SCP,4.0,30,167,MITEK ARTHROSCOPE HRX MEDOS INTERNATIONAL SARL 10886705032075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown