4K C-MNT SCP,4.0,30,167,MITEK
Report
- Report Number
- 1221934-2026-00317
- Event Type
- Malfunction
- Date Received
- January 22, 2026
- Date of Event
- January 7, 2026
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- HRX
- UDI-DI
- 10886705032075
- PMA / PMN Number
- K080560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTOS FOUND AN ARTHROSCOPIC IMAGE, SOME KIND OF WHITE LINE IS SHOWN. NO OTHER ANOMALY WERE FOUND. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 4K C-MNT SCP,4.0,30,167,MITEK WOULD HAVE 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 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.
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: B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. THE CUSTOMER ALSO COMPLAINED ABOUT THE 2 REPEATED SEALING STICKERS ON THE PACKAGING BOX. IT WAS REPORTED THAT THE CUSTOMER SUSPECTED THIS PACKAGING MAY HAVE BEEN OPENED AND RESEALED.
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: B5, H6: DURING COMPLAINT INVESTIGATION IT WAS DETERMINED THAT THE DEVICE MEDICAL PROBLEM CODES REQUIRED AN UPDATE AND THE EVENT DESCRIPTION HAS BEEN UPDATED. INVESTIGATION SUMMARY THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PHOTOS FOUND AN ARTHROSCOPIC IMAGE, SOME KIND OF WHITE LINE IS SHOWN. ADDITIONALLY, TWO WHITE STICKERS WERE OBSERVED ON THE PACKING BOX. NO OTHER ANOMALY WERE FOUND. THE MANUFACTURER PERFORMED AN INVESTIGATION OF THE PHOTOS PROVIDED WITH THE FOLLOWING RESULTS: REGARDING THE REPORTED DOUBLE SEALING STICKERS ON THE PACKAGING BOX, WE WOULD LIKE TO CLARIFY THAT THE LABEL WAS OPENED IN JANUARY 2024 AS PART OF A COMPLAINT INVESTIGATION, DURING WHICH WE INSPECTED THE INVENTORY FOR THE REPORTED ISSUE. AS PART OF THIS PROCESS, THE PACKAGING WAS OPENED AND SUBSEQUENTLY RESEALED. BASED ON OUR INVESTIGATION, THE PRESENCE OF TWO SEALING STICKERS IS THEREFORE RELATED TO THIS INTERNAL INSPECTION ACTIVITY AND DOES NOT INDICATE ANY UNAUTHORIZED OPENING. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 4K C-MNT SCP,4.0,30,167, MITEK WOULD HAVE 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 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.
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 PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THEN, DEPUY SYNTHES TEAM FORWARDED THE DEVICE TO HENKE-SASS WOLF AND AN INVESTIGATION WAS CONDUCTED BY HENKE-SASS WOLF WITH THE FOLLOWING RESULTS: THE ANALYSIS SHOWS THAT THE DISTAL END WAS DAMAGED. THE DISTAL GLASS WAS BROKEN. THIS IS THE REASON FOR THE WHITE BAR. THERE WERE SLIGHT SIGNS OF USE ON THE ENDOSCOPE. THE DAMAGES TO THE PRODUCT WERE CAUSED BY THE CUSTOMER. REGARDING THE REPORTED DOUBLE SEALING STICKERS ON THE PACKAGING BOX, WE WOULD LIKE TO CLARIFY THAT THE LABEL WAS OPENED IN JANUARY 2024 AS PART OF A COMPLAINT INVESTIGATION, DURING WHICH WE INSPECTED THE INVENTORY FOR THE REPORTED ISSUE. AS PART OF THIS PROCESS, THE PACKAGING WAS OPENED AND SUBSEQUENTLY RESEALED. BASED ON OUR INVESTIGATION, THE PRESENCE OF TWO SEALING STICKERS IS THEREFORE RELATED TO THIS INTERNAL INSPECTION ACTIVITY AND DOES NOT INDICATE ANY UNAUTHORIZED OPENING. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 4K C-MNT SCP,4.0,30,167,MITEK WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, A DEFINITE POTENTIAL CAUSE COULD BE TRACED TO THE USER. 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. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.
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: CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER WHO STATED THAT THE CUSTOMER COMPLAINED ABOUT THE 2 REPEATED SEALING STICKERS ON THE PACKAGING BOX, THEY SUSPECT THIS PACKAGING HAVE BEEN OPENED AND RESEALED. REVIEW OF THIS INFORMATION HAS DETERMINED THAT THIS EVENT DOES NOT MEET THE DEFINITION OF A REPORTABLE MALFUNCTION. THEREFORE, THE INITIAL MEDWATCH REPORT WAS SUBMITTED IN ERROR. IF FURTHER INVESTIGATION INDICATES OTHERWISE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
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: CORRECTION H6: THE PRODUCT WAS RETURNED FOR EVALUATION AND DURING COMPLAINT INVESTIGATION IT WAS DETERMINED THAT THE DEVICE MEDICAL PROBLEM CODES REQUIRED AN UPDATE, AND THE REPORTABILITY OF THE FAILURE HAS BEEN UPDATED. INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THEN, DEPUY SYNTHES TEAM FORWARDED THE DEVICE TO HENKE-SASS WOLF AND AN INVESTIGATION WAS CONDUCTED BY HENKE-SASS WOLF WITH THE FOLLOWING RESULTS: THE ANALYSIS SHOWS THAT THE DISTAL END WAS DAMAGED. THE DISTAL GLASS WAS BROKEN. THIS IS THE REASON FOR THE WHITE BAR. THERE WERE SLIGHT SIGNS OF USE ON THE ENDOSCOPE. THE DAMAGES TO THE PRODUCT WERE CAUSED BY THE CUSTOMER. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE 4K C-MNT SCP,4.0,30,167,MITEK WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, A DEFINITE POTENTIAL CAUSE COULD BE TRACED TO THE USER. 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. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE, WHEN THE 4K C-MNT SCP,4.0,30,167,MITEK SCOPE DEVICE WAS TAKEN OUT OF THE BOX, IT WAS OBSERVED THAT THE LENS HAD A WHITE BAR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
UPDATED EVENT DESCRIPTION. IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE, WHEN THE 4K C-MNT SCP,4.0,30,167,MITEK SCOPE DEVICE WAS TAKEN OUT OF THE BOX, IT WAS OBSERVED THAT THE LENS HAD A WHITE BAR. IT WAS FURTHER OBSERVED THAT THERE WERE 2 REPEATED SEALING STICKERS ON THE PACKAGING BOX, SUSPECTING THAT THE PACKAGING HAVE BEEN OPENED AND RESEALED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364712 | 4K C-MNT SCP,4.0,30,167,MITEK | ARTHROSCOPE | HRX | MEDOS INTERNATIONAL SARL | 10886705032075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |