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

Model Number 4515-70-101

Device Problem Malposition of Device (2616)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported that during a total knee arthroplasty procedure, while using the robotic assisted satellite station device, it was observed that there was a 4-6mm notch deep into the anterior cortex.It was reported that the cut went through cortical bone and into the canal.It was reported that the cut plane looked perfect on the plan and they finished the cuts and the rest of the cuts were fine.It was reported that the procedure was completed with a cementless femoral component and that no intervention was required.The device was being used with a base station device and a saw handpiece device.There were no delays in the procedure.There was patient involvement.It was reported that there were no delays in the procedure.There were no injuries, medical intervention or prolonged hospitalization.The reporter stated that the overall outcome was a balanced knee.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.Concomitant medical devices and therapy dates, robotic assisted base station device, september 29, 2022.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: the actual was evaluated and there were no defects observed with the system or the software.It was observed that the system was operating properly.Investigation found that the reported condition could not be confirmed.Review of the device log files determined that the anterior resection plane was verified to be within the correct range of the plan.Therefore the reported condition was not confirmed.The investigation also found that the anterior cortex line acquisition was acquired too medially which can position the femoral implant more posteriorly than expected and consequently notch on the lateral ridge of the trochlea.The assignable root cause could not be determined.

• Brand Name: VELYS SATELLITE 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: 15642392
• MDR Text Key: 305054989
• Report Number: 1818910-2022-19621
• 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
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-101
• Device Catalogue Number: 451570101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1