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

Catalog Number	283573
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H11 additional narrative: d10: concomitant med products and therapy dates: vapr3 footswitch *ea device, 12/5/2024.H4: the device manufacture date is currently unavailable.The product was returned to j&j medtech orthopaedics for evaluation.J&j medtech orthopaedics then conducted visual inspection of the device received.Visual inspection revealed that foot pedal(fms vue/nextra) shows marks of wear as usual in this type of reusable device.Upon the pedals review, it was noted that the left pedal is broken, the broken piece was not returned.The overall complaint was confirmed as the observed condition of the foot pedal(fms vue/nextra) would contribute to the complained device issue.¿ based on the investigation findings the potential cause is traced to the heavy and repeated use, since this device is reusable, the constant manipulation between surgeries and sterilization process can lead to damages in the device.It has been determined that no corrective and/or preventative action is required.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.
Event or Problem Description
Report 1 of 2 for (b)(4).It was reported that during biomed, it was observed that (2x) foot pedal(fms vue/nextra) device left pedal was broken(not working) along with a vapr3 footswitch *ea device pedal missing a button.During in-house engineering evaluation, it was determined that the device left pedal was broken, the broken piece was not returned.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: FOOT PEDAL(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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 21110564
• Report Number: 1221934-2025-00128
• Device Sequence Number: 18322740
• Product Code: HRX
• UDI-Device Identifier: 10886705017010
• UDI-Public: (01)10886705017010
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K954465
• 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): 01/09/2025

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: 283573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/09/2025
• 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