MAUDE Adverse Event Report: DEPUY MITEK LLC US IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K

Model Number EVO4K220

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during a shoulder procedure on (b)(6) 2021, it was observed that the screen on the image management system evolution 4k device went dark twice.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.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 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.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.It was reported that the screen went dark twice using the image management system- evolution 4k.Per service manual operational and diagnostic, no defect was found with the device, therefore this complaint cannot be confirmed.As the reported problem was not confirmed and no defects identified, a root cause for the issue that was experienced by the user cannot be determined.No manufacturing record evaluation is required as no manufacturer or service-related issues were found with the device.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.

• Brand Name: IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K
• Type of Device: IMAGE MANAGEMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11914854
• MDR Text Key: 254586734
• Report Number: 1221934-2021-01717
• Device Sequence Number: 1
• Product Code: LMB
• UDI-Device Identifier: 00817613020987
• UDI-Public: 00817613020987
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVO4K220
• Device Catalogue Number: 242326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1