MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4K C-MNT SCP,4.0,0,167,MITEK; ARTHROSCOPE

Catalog Number	242267
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: d10: concomitant med products and therapy dates: hd epscp,4.0,30,167,mitek device, 378/2024 e3: reporter is a j&j sales representative.Udi: (b)(4).The investigation has been updated to reflect the correct information: investigation summary = > the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: - outer tube damaged, needle outer tube dent(s) outer tube bent - outer tube damaged, distal tip distal tip damaged deep nicks/dings/scratches - illumination distal tip fiber damaged - optical system, optical components distal cover glass/negative damaged scratched/residue proximal cover glass damaged residue ¿ broken (2+ pieces) : device fractured ¿ visual : deformed/bent ¿ labeling : illegible etch per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.The faulty part was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported by the sales rep that during pre surgery for an unspecified surgical procedure on (b)(6) 2024, it was determined that the 4k c-mount endoscope, mitek lock 0 degree x 4 mm x 167 mm device and the hd epscp,4.0,30,167,mitek device scopes were cracked.During in-house engineering evaluation, it was determined that the devices were fractured.There was no procedure involved.No additional information was provided.

• Brand Name: 4K C-MNT SCP,4.0,0,167,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 MA CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 19379650
• Report Number: 1221934-2024-01687
• Device Sequence Number: 7618869
• Product Code: HRX
• UDI-Device Identifier: 10886705032068
• UDI-Public: 10886705032068
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K981751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 242267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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