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

Catalog Number 451570101

Device Problems Positioning Failure (1158); Malposition of Device (2616)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/05/2024

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.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.D4, h4: the device serial/lot number and date of manufacture are unknown at this time.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 would not allow the surgeon to cut pass zero setting on the medial tibial plateau, making it so the resection on the lateral side was a lot more than what was wanted.It was further reported that while in recovery the patient dislocated the knee/implant.They were brought back into surgery later that evening and a 10mm rp crs insert was explanted and a new 14mm rp crs was implanted.There was no delay in the surgery and no injury to the patient.The issue of dislocation of the knee is not related to robotic assisted satellite station device and was related to the insert.The 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.It was additionally reported from the reporter that : the resection was noticed on the planning screen.It would not let surgeon undercut below 0 on the medial side.The lateral side had no adjustability feature available.The procedure was planned for a pressfit.No cement was added to adjust for the overcut.He used a thicker poly insert.No other intervention was needed.Patient is recovering as normal per the surgeon.No manual instruments were used.

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.D4: serial number updated.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.D4, h4: the device serial/lot number and manufacture date were unknown in the initial report.And have been updated accordingly.The device udi has also been updated.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.H11 additional narrative: investigation summary investigation summary: the investigation confirmed the reported issue that the system "did allow the surgeon to cut pass zero setting on the medial tibial plateau." investigation found that the software is performing as intended and the patient may have been a contraindication of the system.The root cause of the reported issue was a potential contraindication of the system.

• 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.C; 700 orthopaedic dr.; warsaw IN 46581
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19171905
• MDR Text Key: 340908707
• Report Number: 1818910-2024-08915
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/24/2024

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?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/29/2024; 05/14/2024; 05/15/2024; Not provided
• Supplement Dates FDA Received: 04/30/2024; 05/14/2024; 05/15/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1