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

Catalog Number	282114
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Event or Problem Description
It was reported that during an unspecified procedure, two fms interface cables were broken and malfunctioning.This is report 1 of 2 for (b)(4).The exact date of the event was unknown.However, it was reported that the event occurred in 2026.
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 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 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.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

• 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: 25002049
• Report Number: 1221934-2026-01691
• Device Sequence Number: 8764323
• 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,Followup

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: P41A42632
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/07/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown