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

Catalog Number 242268

Device Problems Break (1069); Device Contaminated During Manufacture or Shipping (2969); Scratched Material (3020)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that during a knee scope procedure, it was observed that the 4k c-mount endoscope, 30°, 4 mm x 167 mm, mitek lock device was scratched.During service evaluation, it was determined that the device had the following failures: broken (2+ pieces) : device fractured and had foreign substance/debris/cleaning/sterilization.Another like device was used to complete the procedure with a delay of two minutes.There were no adverse consequences to the patient.No additional information was provided.

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.H10 additional narrative: (b)(4) 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 distal tip damaged, illumination distal tip fiber damaged, particulate, optics particulate under distal lens particulate under proximal lens, optical system, optical components broken lenses in optical system distal cover glass/negative damaged scratches/residue cracked/broken negative, cosmetic issue scratches/dents, engraving/identification datamatrix code level b.Broken (2+ pieces) : device fractured visual : deformed/bent visual : foreign substance/debris/cleaning/sterilization 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 manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

• Brand Name: 4K C-MNT SCP,4.0,30,167,MITEK
• Type of Device: 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 02767 ; 3035526892
• MDR Report Key: 19187573
• MDR Text Key: 341462865
• Report Number: 1221934-2024-01363
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• 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: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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