BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24269943 · Received February 5, 2026

    Report

    Report Number
    1221934-2026-00565
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    December 12, 2025
    Report Date
    February 5, 2026
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    HRX
    UDI-DI
    10886705032075
    PMA / PMN Number
    K080560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY==> THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: LABELING : ILLEGIBLE ETCH, VISUAL : DEFORMED/BENT, BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED, VISUAL : SCRATCHED/NICKED. PER SERVICE REPORTS, THIS COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL ROOT CAUSE IS TRACED TO COMPONENT FAILURE FROM WEAR. 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 DEPUY SYNTHES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE 4K C-MNT SCP,4.0,30,167,MITEK DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS INITIALLY REPORTED THAT, DURING STERILE PROCESSING, THREE 4K C-MNT SCP,4.0,30,167,MITEK DEVICES WERE OBSERVED TO HAVE CRACKED LENSES. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328608 4K C-MNT SCP,4.0,30,167,MITEK ARTHROSCOPE HRX MEDOS INTERNATIONAL SàRL 10886705032075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown