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

Model Number 4515-70-101

Device Problem Positioning Problem (3009)

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

Event Date 07/19/2022

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, the anterior and posterior chamfer cuts were off for the trial and final implant.It was reported that the device was being used with a robotic assisted base station 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.The device serial or lot number was unknown; therefore, udi: (b)(4) unknown.Device manufacture date is unknown.The device serial or lot number is unknown concomitant medical devices and therapy dates, robotic assisted base station device, (b)(6) 2022.

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 device was evaluated.Device log files were reviewed for this event and it was determined that the anterior and posterior chamfer resections were not assessed with the pointer.Therefore, the reported condition could not be confirmed.The possible causes for chamfer cuts appearing to be incorrect when visually assessed with a trial or implant were assessed.A review of the posterior condyle acquisitions determined that the most posterior point of each was on the superior edge of the point cloud gathered by the user.A point on the edge of the cloud suggests that more posterior points exist on the anatomy of interest and the most posterior point may not have been acquired.Acquisitions should be acquired and validated by the surgeon as described in the ifu.Further, it is recommended that the accuracy checkpoints be utilized as described in the ifu to reduce the likelihood that array motion causes a similar issue to the one described.No defect was found with the device.The most probable root cause was determined to be due to improper handling from sub-optimal acquisition of anatomical landmarks.

• 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: 15191611
• MDR Text Key: 301741241
• Report Number: 1818910-2022-13709
• 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: 09/15/2022

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 Model Number: 4515-70-101
• Device Catalogue Number: 451570101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 09/15/2022; 10/31/2022
• Supplement Dates FDA Received: 10/31/2022; 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1