MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS; ARTHROSCOPE

Catalog Number	282114
Medical Device Problem Codes	Infusion or Flow Problem (2964); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cable of the fms connect (vue) device was malfunctioning.During in-house engineering evaluation, a test shaver handpiece was wired through the interface cable, and when the shaver was activated, the blue indicator light was flashing on the device indicating the interface cable did recognize the current going through the test shaver, however the pinch valve on the pump was not activating.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported; however, it was reported that the event occurred in 2026.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: investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found external aspect of the cord is in normal used condition.No other anomalies could be observed.A functional test was performed; the device was connected to fms vue pump.The default settings were present on the pump, the blue indicator light was shown indicating the interface cable was recognized by the test pump and was receiving power.No fault code could be observed.A test shaver handpiece was wired through the interface cable.When the shaver was activated, the blue indicator light was flashing on the device indicating the interface cable did recognize the current going through the test shaver, however the pinch valve on the pump was not activating.The overall complaint was confirmed as the observed condition of the fms connect (vue) would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to wear of device's internal components, since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to a non-working interface cable.As per the instructions for use (ifu); prior to use, check the system components for damage.Check the cable integrity carefully.If there are signs of damage, do not use.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.

• Brand Name: FMS
• 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: 24662237
• Report Number: 1221934-2026-01195
• Device Sequence Number: 12032012
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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: 282114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown