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

Model Number 4515-70-101

Device Problems Unintended System Motion (1430); Malposition of Device (2616)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/11/2023

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 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, array clamp device, january 11, 2023.Udi: (b)(4).

Event Description

This is report 1 of 2 for the same event.It was reported from japan that during a total knee arthroplasty procedure, it was observed that during the posterior osteotomy, there was a phenomenon in which the robot arm and the handpiece "floated".It was reported that as a result the osteotomy was larger than planned.It was reported that an error screen was displayed which afterwards the robot stopped being used.It was reported that the severely cut bone was fixed with fixsorb and a primary implant was used.It was reported that the surgeon operated femur first, osteotomy up to the front of the femur and was performed without any problems.Based upon the returned photo, the array had fallen off of the array clamp and was rotating internally.It was further reported that the array was removed once and re-attached again during the medical operation in order to facilitate the operation.This issue occurred while using the robotic-assisted solution satellite station and robotic assisted array clamp 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.

Event Description

This is report 1 of 2 for the same event.It was reported from japan that during a total knee arthroplasty procedure, it was observed that during the posterior osteotomy, there was a phenomenon in which the robot arm and the handpiece "floated".It was reported that as a result, the osteotomy was larger than planned.It was reported that an error screen was displayed and afterwards the robot stopped being used.The reporter stated that the ¿severely¿ cut bone was fixed with bone cement in order to correct the cut.Multiple attempts were made to obtain additional information regarding the severity of the cut bone, however no further information was provided.It was reported that the surgeon operated femur first, osteotomy up to the front of the femur and was performed without any problems.Based upon the returned photo, the array had fallen off of the array clamp and was rotating internally.It was further reported that the array was removed once and re-attached again during the medical operation in order to facilitate the operation.This issue occurred while using the robotic-assisted solution satellite station and robotic assisted array clamp device.There were no delays in the procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.  the procedure was reported to have been completed as initially planned and there was no impact to the expected surgical outcome.There were no negative outcomes to the patient reported.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.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 array became detached either accidentally or intentionally during the anterior step cut.Since the cut proceeded following the detachment, this led to the posterior cut being off.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to the user.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Additional information was received that the device was being used with a robotic assisted array set knee.

• 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 ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16326932
• MDR Text Key: 309128827
• Report Number: 1818910-2023-01437
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: 10603295519492
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/18/2023

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: 01/10/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 03/20/2023; 04/14/2023
• Supplement Dates FDA Received: 02/09/2023; 04/12/2023; 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1