4K C-MNT SCP,4.0,30,167,MITEK
Report
- Report Number
- 1221934-2025-02362
- Event Type
- Malfunction
- Date Received
- June 27, 2025
- Date of Event
- January 1, 2025
- Report Date
- June 27, 2025
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL
- Product Code
- HRX
- UDI-DI
- 10886705032075
- PMA / PMN Number
- K080560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 PRODUCT HAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTOS FOUND NO OBSERVATIONS PERTAINING TO THE NATURE OF THE REPORTED EVENT OR ANY OTHER ANOMALY. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE 4K C-MNT SCP,4.0,30,167,MITEK WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, A POTENTIAL CAUSE CANNOT BE ESTABLISHED. MULTIPLE FACTORS ARE ASSOCIATED WITH THIS TYPE OF FAILURE, AND THE COMPLAINT DEVICE NEEDS TO BE PHYSICALLY RECEIVED AND EVALUATED IN OUR SERVICE CENTER TO DETERMINE A POTENTIAL CAUSE OF WHY THE CUSTOMER EXPERIENCED THE FAILURE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.
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: D9, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.
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: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: OTHER DAMAGES CAUSED BY CUSTOMER, OUTER TUBE DAMAGED, NEEDLE OUTER TUBE DENT(S) DEEP DENT, OUTER TUBE DAMAGED, DISTAL TIP DISTAL TIP DAMAGED, ILLUMINATION DISTAL TIP FIBER DAMAGED, OPTICAL SYSTEM, OPTICAL COMPONENTS BROKEN LENSES IN OPTICAL SYSTEM DISTAL COVER GLASS/NEGATIVE DAMAGED SCRATCHES/RESIDUE, COSMETIC ISSUE SCRATCHES/DENTS LABELING : ILLEGIBLE ETCH, VISUAL : DEFORMED/BENT, 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. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO NON-CONFORMANCE WAS IDENTIFIED.
IT WAS REPORTED THAT THE 4K C-MNT SCP,4.0,30,167 DEVICE WAS SHOWING A DARK IMAGE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 939446 | 4K C-MNT SCP,4.0,30,167,MITEK | ARTHROSCOPE | HRX | MEDOS INTERNATIONAL SÃ RL | 1613431 | 10886705032075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |