MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD C-MNT SCP,2.7,30,75,MITEK; ARTHROSCOPE

Catalog Number	242276
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection it was observed that the pictures of 2x hd epscp,1.9,30,60,mitek scope devices and a hd c-mnt scp,2.7,30,75,mitek scope device were blocked/out of focus during testing.This event did not occur during surgery.There were no reported adverse consequences to the patient.No additional information could be provided.This is report 3 of 3 for (b)(4).
Additional Manufacturer Narrative
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: 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 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: visual : scratched/nicked, broken (2+ pieces) : chipped/shaved/delaminated, visual : deformed/bent, labeling : illegible etch, usage : use error/misuse 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 serial number, and no non-conformance was identified.
Additional Manufacturer Narrative
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: upon further 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: - other damages caused by customer - outer tube damaged, needle scratches outer tube dent(s) deep outer tube bent bulge - outer tube damaged, distal tip distal tip damaged dings - illumination distal tip fiber damaged - particulate, optics - optical system, optical components broken lenses in optical system - cosmetic issue scratches/dents - engraving/identification datamatrix code level a visual : scratched/nicked, broken (2+ pieces) : chipped/shaved/delaminated, visual : deformed/bent, labeling : illegible etch, usage : use error/misuse per service report, this complaint was confirmed.The housing, optical, label and tube 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 C-MNT SCP,2.7,30,75,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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 23082786
• Report Number: 1221934-2025-03576
• Device Sequence Number: 9812396
• Product Code: HRX
• UDI-Device Identifier: 10886705032143
• UDI-Public: (01)10886705032143
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 242276
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 12/15/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/24/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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