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

Catalog Number	284508
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional 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.H11: additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
Report 1 of 2 for (b)(4).It was reported that during pre-surgery for anterior cruciate ligament repair procedure, it was observed that after 2x inflow tubing fms vue 24pk devices were set, arthromatic (perfusate) was flowed, but the device was damaged causing arthromatic to leak.Another like 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.
Additional 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.H11: additional narrative: b5: it was reported that the quantity of devices involved in the event was changed from two to one and the event comprised of 1x inflow tubing fms vue 24pk device.
Additional 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.H11: additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed the tube cut/cracked at one portion.No other anomalies were noted.A functional test was unable to be performed due to the post-manufacturing damage.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, the potential cause is traced to procedural variables, such handling of the device or product interaction during the set up and preparation of the pump when installing the tubbing set.When the tubing was placed into the roller pump, the tubing was grabbed by the edge of the rolling part causing a slit.As per ifu: 1) to avoid damage to the tubing make sure that tubing is centered on the groove of the pump.2) when installing tubing, make sure tubing is not kinked or collapsed.3) when positioning the fill chamber in the bracket, make sure that the fill chamber symbol is facing toward the user and tubing is not twisted.4) improper positioning could cause the tube to twist and obstruct the flow of fluid.Properly handling and¿attention to the approved use of the device diminishes the risk of 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.Device history review a manufacturing record evaluation was performed for the finished device 3013484, and no non-conformances related to the reported complaint condition were identified.

• 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 23345799
• Report Number: 1221934-2025-03988
• Device Sequence Number: 9461148
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: (01)10886705023066(10)3013484(17)270130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 3013484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/12/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 10/30/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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