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

Model Number 4515-70-101

Device Problems Off-Label Use (1494); Positioning Problem (3009)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

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 narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

It was reported that during a surgical procedure, it was observed that the distal femoral cut was out of plane while making the cut on the robotic-assisted solution satallite station.It was reported that approximately 2mm too much was taken out of the medial femoral condyle and 1mm (not enough bone) off of the lateral femoral condyle.It was further reported that the system initialization failed at the beginning of the system startup.Rcu1 con000 was the only error code that appeared.The doctor decided to do the procedure off label.It was reported that the procedure was done while on the cart.It was also reported that the system was re-booted and re-started and the procedure went without issue until the distal femoral cut.The device was being used with a robotic-assisted solution base station.It was reported that in the end the implant was correctly aligned and implanted.It was not reported if there were any delays in the surgical 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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 returned for evaluation.During repair, an evaluation was performed.The investigation confirmed the reported issue of system pop up error rcu1 con000 during system initialization and the reported issue of the inaccurate distal femoral cut.During analysis of the log files of the device, it was identified that the distance from the pointer to the planned cut that was displayed on the 'check resection screen' did not reflect the actual difference between the resection performed and planned.It was determined that this was due to movement of the femur array between the first cutting session of the distal plane and the second cutting session.Additionally, it was determined that the femur checkpoint was acquired on the femur array, which was ineffective to detect any movement of the femur array.If the femur array moves, then the femur checkpoint that was placed on the tracker would move as well, resulting in the system considering that the checkpoint was at the same position.Acquiring the femur checkpoint on the femur array is a user error.Therefore, the distance from the pointer to the planned cut that was displayed on the 'check resection screen' resulted in a perception of an inaccurate cut.The details of the reported issue were discussed with the surgeon.The surgeon commented several times that this was a one-time occurrence.This issue appears to be related to user inexperience with use of the system.After the discussion with the surgeon regarding the use related aspects of the reported issues, the surgeon has completed subsequent cases without any issues, thus supporting that the issue is due to user error.The assignable root cause of the reported issue of inaccurate cut for the distal femoral cut was determined to be due to user error during the distal femoral cut.Regarding the rcu1 con000 error code, the analysis of the log files for the case identified that the tka application software start-up failed as the system had not yet successfully booted and established a link to the rcu application/software was not running after the expected maximum time-out of 2 minutes.It was determined that the most probable root cause was a hardware related start-up failure (incomplete cold-start reset) or an issue with a slow cold-start (e.G.Stabilization) of the rcu power-supply.Subsequent hardware reset and reboots worked without any indication of errors.Since the issue, no follow-up boot-problems of the system have been recorded to the date of this analysis.The root cause could not be determined, as the system performed without errors after a reboot.Additionally, a field service engineer went on-site and checked the system performance for the satellite station and base station.The system was found to be performing to specification and no failures were found with the system.No issues or defects with the system or software were identified.

• 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 IRELAND; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthpaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 13046499
• MDR Text Key: 282632811
• Report Number: 1818910-2021-28229
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

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: 12/02/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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