MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4K C-MNT SCP,4.0,30,167,MITEK; ARTHROSCOPE

Catalog Number 242268

Device Problems Break (1069); Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

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.H10 additional narrative: 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 damaged, distal tip shaver damage to distal tip.Optical system, optical components distal cover glass/negative damaged.Moisture, moisture in system per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.The faulty parts 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.Device history review a manufacturing record evaluation was performed for the finished device serial number (b)(6) and no non-conformance was identified.

Event Description

It was reported by the sales rep that during a shoulder scope procedure performed on (b)(6) 2023 it was observed that the 4k c-mnt scp,4.0,30,167,mitek scope device had a crack in it.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.During in-house engineering evaluation it was observed that the outer tube was damaged, the needle of the outer tube was dented distal tip shaver tip was damaged, optical components distal cover glass/negative was damaged, and there was moisture in the system.No additional information was provided.

• Brand Name: 4K C-MNT SCP,4.0,30,167,MITEK
• Type of Device: 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: 18594564
• MDR Text Key: 334061569
• Report Number: 1221934-2024-00294
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705032075
• UDI-Public: 10886705032075
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1