MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS CONNECT (VUE); ARTHROSCOPE

Catalog Number	282114
Medical Device Problem Codes	Use of Device Problem (1670); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.Device was used for treatment, not diagnosis.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 product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the overall device surface with signs of usage.No other anomalies were noted.A functional test was performed for the device using a fms vue pump and a shaver handpiece, which was wired through the interface cable.The default settings were present on the pump, and the blue indicator light was shown showing that the interface cable was recognized.No fault code could be observed.Test revealed that, although the shaver was able to be activated/powered on and the blue indicator light was flashing on the device, the suction function could not be activated as intended.The overall complaint was confirmed as the observed condition of the fms connect (vue) would have contributed to the complained device issue.¿ based on the investigation the root cause is traced to a component failure, where in combination of a constant manipulation between surgeries and the sterilization process, conditions can lead to a non-working interface cable and therefore failure.As per the instructions for use; prior to use, check the system components for damage.Check the cable integrity carefully.If there are signs of damage, do not use.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 depuy synthes 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 evaluation of the device, it was determined that the fms connect (vue) device had a suction failure.It was initially reported that the device cable was broken and not functioning.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.

• Brand Name: FMS CONNECT (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 ; 9083863534
• MDR Report Key: 23726330
• Report Number: 1221934-2025-04631
• Device Sequence Number: 21501039
• Product Code: HRX
• UDI-Device Identifier: 10886705020485
• UDI-Public: (01)10886705020485
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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: 282114
• Device Lot Number: R15A42771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown