MAUDE Adverse Event Report: DEPUY MITEK LLC US REMOTE CONTROL(FMS VUE/NEXTRA); ARTHROSCOPE

Catalog Number	283551
Medical Device Problem Codes	Use of Device Problem (1670); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that during set up for an unspecified surgical procedure on (b)(6) 2024, the remote control(fms vue/nextra) device x2 would not rotate or oscillate and made a beeping noise along with a shaver handpiece 2.0 with buttons device.During in-house engineering evaluation, it was determined that the remote control(fms vue/nextra) device run/stop button activated without fully pressing the button, only the shaver suction ¿-¿ and speed ¿-¿ buttons worked, the rest of the buttons didn¿t work as intended.There was no procedure involved.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.D4: the device expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.Udi: (b)(4).Investigation summary : the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection and functional testing of the returned device.Upon visual inspection revealed that remote control(fms vue/nextra) has marks of use, as usual in this type of reusable devices.The power cord as well as the connector pins do not show structural anomalies.The device buttons were found in normal shape.A functional test was performed by connecting the device to an fms vue pump.It was connected without restriction, the run/stop button activated without fully pressing the button, only the shaver suction ¿-¿ and speed ¿-¿ buttons worked, the rest of the buttons didn¿t work as intended.The overall complaint was confirmed as the observed condition of the remote control(fms vue/nextra) would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced the continuous and heavy use, since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to internal wear of electrical components and consequently the button failure.As per ifu inspect all equipment and cables periodically for wear.If damage is noted, replace or return to repair service center, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek 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: REMOTE CONTROL(FMS VUE/NEXTRA)
• 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: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 19517776
• Report Number: 1221934-2024-02034
• Device Sequence Number: 18277943
• Product Code: HRX
• UDI-Device Identifier: 10886705016990
• UDI-Public: 10886705016990
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K041824
• 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): 06/12/2024

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: 283551
• Device Lot Number: M27AB0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/12/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown