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

Model Number 4515-70-100

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

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.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 Description

It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic-assisted solution base station, the foot pedal cord was "shorting out".It was working intermittently and erratically causing the software to move back and forth through screens.It was reported that this issue occurred during pointer acquisitions.It was reported that moving the cord when the foot pedal wasn't activating affected the operation.Holding the cord caused it to behave erratically.It was reported that the case went to manual instrumentation.There were a slight delay in the case in order to switch to manual instrumentation.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.

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.The actual device was evaluated and the reported condition was confirmed.The assignable root cause for the foot pedal cord shorting out is due to premature wear.The system is performing as intended following replacement of the foot pedal cord with a new one.

• Brand Name: VELYS BASE STATION
• Type of Device: 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: 16775630
• MDR Text Key: 313641408
• Report Number: 1818910-2023-08170
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519515
• UDI-Public: 10603295519515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-100
• Device Catalogue Number: 451570100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1