MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD C-MNT SCP,1.9,30,60,MITEK; ARTHROSCOPE

Catalog Number	242274
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
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.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 a photo was provided for evaluation.Visual inspection of the returned photo 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 hd c-mnt scp,1.9,30,60,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.
Event or Problem Description
It was reported that when the hd c-mnt scp,1.9,30,60,mitek device was taken out of the box, it was observed that a black dot shaped foreign matter was found inside the mirror.There were no adverse consequences to the patient.No additional information could be 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: the product was returned for evaluation with the following results: the device was tested against specifications and found no deviations.The image on the camera fully complied with the specifications.No black dot was visible.The devices are checked against specifications before shipping.It is therefore assumed that the devices was shipped in perfect condition.The overall complaint was not confirmed as the observed condition of the hd c-mnt scp,1.9,30,60,mitek would have not contributed to the complained device issue.Based on the investigation findings, the potential cause cannot be established since no defect was found.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.A manufacturing record evaluation was performed for the finished device 1972597, and no non-conformances were identified.

• Brand Name: HD C-MNT SCP,1.9,30,60,MITEK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; 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 ; 3035526892
• MDR Report Key: 22357577
• Report Number: 1221934-2025-02399
• Device Sequence Number: 7997500
• Product Code: HRX
• UDI-Device Identifier: 10886705032129
• UDI-Public: (01)10886705032129
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: 242274
• Device Lot Number: 1972597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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