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

Catalog Number 451570101

Device Problem Positioning Failure (1158)

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

Event Date 01/12/2024

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.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.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic-assisted solution satellite station device when performing the tibia cut the robot jumped positions.Then cut as per normal.When robot went to cut the anterior chamfer cut it was clearly n the wrong position.It was reported that the device was mounted to the bedrail.It was reported that the procedure was completed with conventional cutting blocks.There was a 10 minute delay in the 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.

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 there were no defects found with the system and software.A review of the device log files was performed for this event.The investigation of the log files determined, that the issue the robot jumped position, during the tibia cut was confirmed.There are indications, that the robotic assisted device was not transferred to the bedrail, causing the robot to move, during operation.The position of the camera was changed, during the first cutting step of the workflow.Causing recalibration of the camera-array distance.Which resulted, in the system to move to the home position'.This would have contributed to the 2nd reported issue of the robot's position being wrong, during the anterior chamfer cut.The investigation found no issues or defects.And the system was operating properly and accurately.The assignable root cause was determined, to be due to user.

• Brand Name: VELYS SATELLITE STATION
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46581
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18570090
• MDR Text Key: 333555834
• Report Number: 1818910-2024-01641
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: 10603295519492
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 451570101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1