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

Catalog Number	242274
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
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.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: other damages caused by customer, outer tube damaged, needle outer tube dent(s) deep dent outer tube bent bent/bulged at needle base, outer tube damaged, distal tip distal tip damaged, optical system, optical components broken lenses in optical system, cosmetic issue scratches/dents.Labeling : illegible etch, visual : deformed/bent, broken (2+ pieces) : chipped/shaved/delaminated, visual : scratched/nicked 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.
Event or Problem Description
It was reported that prior to an unspecified surgical procedure it was observed that the hd c-mnt scp,1.9,30,60,mitek scope device was cracked.During in-house engineering evaluation it was determined that the device was broken in two pieces.This event did not occur during a surgical procedure.There were no adverse consequences to the patient.No additional information could be provided.
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: during complaint investigation it was determined that the device evaluation required an update.Updated investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: usage : use error/misuse, labeling : illegible etch , visual : deformed/bent, broken (2+ pieces) : chipped/shaved/delaminated, visual : scratched/nicked, - other damages caused by customer, - outer tube damaged, needle outer tube dent(s) deep dent outer tube bent bent/bulged @ needle base - outer tube damaged, distal tip distal tip damaged - optical system, optical components broken lenses in optical system - cosmetic issue scratches/dents per service report, this complaint was 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 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.

• Brand Name: HD C-MNT SCP,1.9,30,60,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: 22577711
• Report Number: 1221934-2025-02712
• Device Sequence Number: 9566499
• Product Code: HRX
• UDI-Device Identifier: 10886705032129
• UDI-Public: (01)10886705032129
• Combination Product (Y/N): N
• 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

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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