MAUDE Adverse Event Report: DEPUY IRELAND VELYS BASE STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Connection Problem (2900); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Event or Problem Description
It was reported that during a total knee arthroplasty surgical procedure, it was observed that the robotic assisted base station power cord had come off two times where it lost power during the case and went straight to dark screen.It was reported that the power cord did not lock in place and that there may have been arching from the connection to the console.It was reported that there were no delays in the surgical procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Evaluation of the power cord was able to replicate the reported issue with the base station.Therefore, the reported problem was confirmed.The assignable root cause for the reported issue is component wear.Upon replacement of the power cord, the system was confirmed to be performing within specification and is ready for use.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VELYS BASE STATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17396088
• Report Number: 1818910-2023-15195
• Device Sequence Number: 7657399
• Product Code: OLO
• UDI-Device Identifier: 10603295519515
• UDI-Public: 10603295519515
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K202769
• 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
• Report Date (Section B): 07/26/2023

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: 451570100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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