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

Catalog Number 451570101

Device Problems Malposition of Device (2616); Complete Loss of Power (4015); Intermittent Loss of Power (4016)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/07/2023

Event Type  malfunction  

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 it was noticed that the robot stopped moving during setup.Setup was re-started and initialization was completed.During the anterior cut the saw was cutting out non stop.After stopping to check cut the cuts, they were 4mm off during anterior and 2mm interior.It was reported that the procedure was finished manually.It was reported that the device was being used with a robotic assisted saw handpiece device.There were no delays 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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.D10, concomitant medical devices and therapy dates, saw handpiece device, (b)(6), 2023.Udi: (b)(4).

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: reporter additionally reported that the anterior resection was off by 5mm too much.Posterior condyle resections were off by 2mm medially and 4mm to much on the lateral condyle resection.The robot was abandoned and all cuts were re-done with standard instrumentation.It was reported that the issue was detected after anterior resection via the pointer.Cemented implants were used, case was salvaged very accurately with move to instrumentation.Arrays were left in place and gaps were checked after finishing case with standard instrumentation.Out come gaps were satisfactory to surgeon both digitally as well as to touch and feel through range of motion.

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.Evaluation was able to confirm three reported issues: issue 1: "robot stopped moving during setup.Setup restarted and the initialization was complete." issue 2: "during anterior cut the saw was cutting out non stop." issue 3: "after stopping to check cut the cuts were 4 mm off during anterior and 2 mm interior.Finished manual" for the first issue it was found that the right foot pedal was not being pressed down during the homing process.The log files shows that throughout the homing process the foot pedal was being released causing the homing process to stop.Press and hold blue foot pedal to complete robotic-assisted device initialization.For the 2nd issue, the investigation found that the arrays were being blocked during operation.The saw array and the array of the bone being cut must be visible during operation otherwise the power to the saw will be cut.This will lead to the user experiencing the "saw cutting out" issue.It is essential to maintain direct line of the sight between the saw array and the camera.The third issue the investigation found that no single root cause could be established.Indications that the robotic assisted device was not transferred to the bedrail causing the robot to move during operation, leg motion was visualized during operation, probable hard bone was visualized during distal and anterior cuts, potential array motion visualized on the anterior cut, and/or handling of the saw handpiece.Skiving(angular deflection) was also visualized on the distal, anterior, and posterior cuts and may be attributed to the possible hard bone, and saw handling technique utilizing side to side motion of the handpiece was observed on multiple cut steps.The investigation found no issues or defects, and the system was operating properly and accurately.Therefore, the most probable cause for the described issue cannot be established.The verify checkpoint step was not repeated after the cuts to determine if the arrays had moved.There were no defects found with the system and software.Review of the device service history record indicates that the related service records.Service history record review result is not relevant to the current complaint.The assignable root cause was determined to be due to user error and cause not established.

• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17743521
• MDR Text Key: 323387342
• Report Number: 1818910-2023-18665
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: 10603295519492
• 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,Followup
• Report Date: 09/14/2023

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
• 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: 09/07/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/22/2023; 11/06/2023
• Supplement Dates FDA Received: 09/28/2023; 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1