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

Model Number 4515-70-101

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/12/2023

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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: 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, base station device, june 12, 2023.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 satellite station device, it was observed that the saw stuttered.It was reported that the cuts were "continually inaccurate".Multiple attempts were made to gain additional information, and no additional information was provided.It was reported that all saw interface connections were check and were satisfactory.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.The actual device was returned for evaluation.During evaluation it was determined that the reported condition of saw stuttered could be confirmed.It was found that when the device was run, the blade tip appeared to oscillate up and down (out of plane) while the motor was driven.It is unknown when this failure occurred.Review of the device log files for this event determined that inaccurate cuts "continually" could not be confirmed but one case was confirmed as inaccurate possibly related to the saw.The most probable cause of the saw issue is loss of performance.(premature wear).No defects were found with the system or software.The overall assignable root cause was determined to be due to user/improper handling and component failure and premature wear.B5: the event description has been updated to include the additional returned device.D10, concomitant medical devices and therapy dates, base station device, robotic assisted saw handpiece device.On (b)(6) 2023.

Event Description

This is report 1 of 2 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic-assisted solution satellite station device and the robotic assisted saw handpiece device, it was observed that the saw stuttered.It was reported that the cuts were "continually inaccurate".Multiple attempts were made to gain additional information, and no additional information was provided.It was reported that all saw interface connections were check and were satisfactory.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.

• 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: 17184025
• MDR Text Key: 317917798
• Report Number: 1818910-2023-12699
• 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: 06/21/2023

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 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: 06/12/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1