MAUDE Adverse Event Report: DePuy Mitek LLC US FMS VUE; Arthroscope

Catalog Number	284002
Medical Device Problem Codes	Increase in Pressure (1491); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to surgery, the pressure sensor on the fms vue device went off.It was further reported that the high-pressure light came on.This event did not occur during surgery.  there were no reports of injuries, medical intervention or prolonged hospitalization.  all available information has been disclosed. .
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was returned to depuy synthes service center for evaluation.A service evaluation was performed accordance with depuy synthes procedure and the following defects were identified: functional : intermittent operation, error code: fc004, visual : component damaged.The pump were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The reported complaint was confirmed based on the service evaluation results.The investigation traced the potential cause to faulty parts from wear.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.

• Brand Name: FMS VUE
• Common Device Name: Arthroscope
• Manufacturer (Section D): DePuy Mitek LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50945349
• Report Number: 1221934-2026-04484
• Device Sequence Number: 9534235
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial

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: 284002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown