BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22063836 · Received May 21, 2025

    Report

    Report Number
    1221934-2025-01859
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 1, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HRX
    UDI-DI
    10886705032075
    PMA / PMN Number
    K080560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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. 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, USAGE : USE ERROR/MISUSE, BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED, VISUAL : SCRATCHED/NICKED. PER SERVICE REPORTS, THIS COMPLAINT WAS CONFIRMED. THE DEFECTIVE PARTS NEED TO BE REPLACED TO RESOLVE THE ISSUES. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL ROOT CAUSE IS TRACED TO USER ERROR. 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. 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. H11 ADDITIONAL NARRATIVE: : DURING COMPLAINT INVESTIGATION IT WAS DETERMINED THAT THE DEVICE EVALUATION REQUIRED AN UPDATE. 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, USAGE : USE ERROR/MISUSE, BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED, VISUAL : SCRATCHED/NICKED. OTHER. DAMAGES CAUSED BY CUSTOMER, OUTER TUBE DAMAGED, NEEDLE, OUTER TUBE BENT, OUTER TUBE DAMAGED, DISTAL TIP, DISTAL TIP DAMAGED, HIGH VOLTAGE FLASHOVER FROM ELECTRODE. ILLUMINATION, DISTAL TIP FIBER DAMAGED, PARTICULATE, OPTICS, PARTICULATE UNDER DISTAL LENS, OPTICAL SYSTEM, OPTICAL COMPONENTS, BROKEN LENSES IN OPTICAL SYSTEM, DISTAL COVER GLASS/NEGATIVE DAMAGED SCRATCHES/RESIDUE, COSMETIC ISSUE, SCRATCHES/DENTS. PER SERVICE REPORT, THIS COMPLAINT WAS CONFIRMED. THE TUBE, LABEL, OPTICAL, HOUSING WERE REPLACED TO RESOLVE THE ISSUES. AFTER REPAIR, THE DEVICE WAS FOUND TO BE WORKING ACCORDING TO THE SPECIFICATIONS. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL ROOT CAUSE IS TRACED TO USER ERROR. 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. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER AND NO NON-CONFORMANCE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SCOPING SURGICAL PROCEDURE IT WAS OBSERVE THAT THE 4K C-MNT SCP,4.0,30,167,MITEK LOCK HAS SCOPE DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. THIS EVENT DID NOT OCCUR DURING 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
    884752 4K C-MNT SCP,4.0,30,167,MITEK ARTHROSCOPE HRX MEDOS INTERNATIONAL SARL 10886705032075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown