MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,2.7,30,75,MITEK; ARTHROSCOPE

Catalog Number	242107
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure it was observed that the hd epscp,2.7,30,75,mitek device was cloudy.There was no delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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: 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, distal tip distal tip damaged illumination distal tip fiber damaged optical system, optical components distal cover glass/negative damaged cosmetic issue scratches/dents engraving/identification datamatrix code level a moisture in system moisture at distal end labeling: illegible etch, visual: deformed/bent, broken (2+ pieces) : chipped/shaved/delaminated, functional: moisture/water damage per service report, this complaint [was / was not] confirmed.The label, tube, 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 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 serial number, and no non-conformance was identified.

• Brand Name: HD EPSCP,2.7,30,75,MITEK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24132484
• Report Number: 1221934-2026-00298
• Device Sequence Number: 16038304
• Product Code: HRX
• UDI-Device Identifier: 10886705031962
• UDI-Public: (01)10886705031962
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 242107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown