MAUDE Adverse Event Report: DEPUY MITEK LLC US INFLOW TUBING FMS VUE 24PK; ARTHROSCOPE

Catalog Number	284508
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
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 not returned to j&j medtech orthopaedics, however a video was provided for evaluation.Visual inspection of the returned video found that the tubbing is installed in the pump and when the pump starts, the reservoir is filled and the pressure gets lower.The overall complaint was confirmed as the observed condition of the inflow tubing fms vue 24pk would have contributed to the complained device issue.¿ based on the investigation findings, a potential cause cannot be established.Multiple factors are associated with this type of failure, and the complaint device needs to be physically received and evaluated to determine a potential cause of why the customer experienced the failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that during an unspecified surgical procedure the inflow tubing fms vue device was being used along with a fms vue pump device when the reservoir is pre-filled normally, but when the specialist started the procedure the console started to lower the pressure and this filled the reservoir completely, the doctor informed that this is the hose and requests to change it for another one it works normally, but the console after a certain time lowers the pressure and the water stops flowing, the hose was sent for review.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 for the same event.

• Brand Name: INFLOW TUBING FMS VUE 24PK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23479793
• Report Number: 1221934-2025-04240
• Device Sequence Number: 18766755
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: (01)10886705023066(10)3013764(17)270227
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K951843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: 284508
• Device Lot Number: 3013764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown