MAUDE Adverse Event Report: Medos International SARL 4K C-MNT SCP,4.0,30,167,MITEK; Arthroscope

Catalog Number	242268
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a shoulder arthroscopy surgical procedure it was observed that the 4k c-mnt scp,4.0,30,167,mitek scope device was cracked.It was reported that a new scope was attached and the device worked fine.During in-house engineering evaluation it was determined that the device was broken (2+ pieces): chipped/shaved/delaminated.It was reported that there was no patient injury.The exact date of the event was not reported; however, it was reported that the event occurred in 2026.No additional information was provided.
Additional Manufacturer Narrative
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 actual device and a photo were returned for evaluation.Visual inspection of the returned photo found no observations pertaining to the nature of the reported event or any other anomaly.The product was returned to depuy synthes service center for evaluation then, the device was forwarded to oem and the following defects were identified: - other damages caused by customer - outer tube damaged, distal tip distal tip damaged deep scratches/knicks shaver damage to distal tip fibers sunken in - illumination distal tip fiber damaged - optical system, optical components broken lenses in optical system distal cover glass/negative damaged - cosmetic issue scratches/dents rust/discoloration - engraving/identification datamatrix code level a visual : scratched/nicked, broken (2+ pieces) : chipped/shaved/delaminated, visual : deformed/bent and labeling : illegible etch the defective parts needs to be replaced to resolve the issues.The reported complaint was confirmed based on the service evaluation results.The investigation traced the potential cause to user error.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history lot = > a manufacturing record evaluation was performed for the finished device serial number, and no non-conformance was identified.

• Brand Name: 4K C-MNT SCP,4.0,30,167,MITEK
• Common Device Name: Arthroscope
• Manufacturer (Section D): Medos International SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): Medos International SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50843631
• Report Number: 1221934-2026-04251
• Device Sequence Number: 9957647
• Product Code: HRX
• UDI-Device Identifier: 10886705032075
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242268
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown