MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS SATELLITE STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570101
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	Bone Notching (4890)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional 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.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
This is report 2 of 2 of (b)(4).It was reported that during a total knee arthroplasty (tka) surgical procedure it was observed that the velys saw handpiece device the anterior chamfer cut the saw array became loose and swung off.Surgeon then put it back on and allowed his fellow to finish the cut.The device was in use with the velys base station device and the velys satellite station device.There was no delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.
Additional 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.H11 additional narrative: results received from the engineering team: investigation summary: the investigation found 2 issues reported: issue1: the investigation could confirm the reported issue of "during the anterior chamfer cut the saw array became loose and swung off.Surgeon then put it back on and allowed his fellow to finish the cut." issue2: the investigation could confirm the reported issue of "when putting the femur trial on it was aggressively way more flexed than planned.Please see attached photo.Surgeon feathered with a manual saw to make the trial fit better however it still stayed incredibly flexed.Surgeon would like to know what happened as soon as possible." issue 1 is related to the saw array, and not related to the base or satellite station.The array set investigation has been documented under pi-17728095221907943.The issue was investigated and reviewed by the systems team.Issue 2: the investigation could confirm the reported issue based on the photo provided.The investigation found that the likely root cause to the issue is a combination of leg/robot movement, potential saw blade deflection, and saw handling technique.Array motion of the saw array would not have caused the described issue.The pointer tool was not utilized to measure the cuts so an evaluation of over or under resected surfaces cannot be performed in the log review.The investigation found that in all the log files analyzed multiple messages of the following are seen throughout all cuts: [saw disabled] saw blade plane deviates too much from the cutting plane.[saw disabled] saw blade 'tip' point is too far from cut reference point.This indicates that there was enough leg/robot movement during all of the femoral cut steps that would cause power to the saw handpiece to be cut.The constant cutting of power could lead to deviation in the cuts if proper saw handling technique is not followed.To ensure flat resection surfaces: - wait for the motor of the saw to reach full speed prior to engaging the bone.- hold the saw handpiece gently to allow the robotic-assisted device to adjust the resection plane.- while cutting, advance or retract the saw blade, avoiding mediolateral movements.This will ensure the sharp end of the saw blade is used to resect bone, not the sides of the saw blade.During operation the robot moves rapidly.Robot movement is generally caused by the system not being properly mounted to the bedrail.The patient¿s leg must be stabilized during resections.The surgeon¿s preferred leg holder may be used to stabilize the leg if it does not inhibit the function of the velys¿ robotic-assisted solution.Prior to each resection, ensure the leg is stabilized in the desired position.The ifu 090260022sw19 rev b on page 157 outlines: any large leg/robot movement will require a rapid adjustment by the robotic-assisted device and can potentially introduce inaccuracy.The investigation found that potential saw blade deflection may have occurred but cannot be confirmed in the log review.The hip moves slightly during the anterior and anterior chamfer resections but returns to its original position which indicates that the flexed fit of the implant was probably not due to array motion.There is potentially some skiving due to the resection cutting technique during the anterior cut.The skiving could make the anterior cut a bit under resected which would affect how the implant was placed on.The pointer tool was not utilized to measure the resected surfaces so saw blade deflection cannot be confirmed.There were no defects found with the system and software.The user indicated that there was no negative impact to the patient outcome and no patient harm and the investigation indicates that the system was behaving properly.Recommendations: it is recommended that the user follow the guidance on ifu-090260022sw19 rev b pages 56-57 instrumentation: assemble array to clamp.It is recommended that the user follow the guidance on ifu 090260022sw19 rev b pages 111-115 system setup: robotic-assisted device transfer to the bedrail.It is recommended that the user follow the guidance on ifu-090260022sw19 rev b page 124 intraoperative use: attaching the bone array to the array clamp it is recommended that the user follow the guidance on ifu 090260022sw19 rev b pages 157-159 intraoperative use: performing resections root cause: issue 2: the investigation found that the likely root cause to the issue is a combination of leg/robot movement, potential saw blade deflection, and saw handling technique.Array motion of the saw array would not have caused the described issue.The pointer tool was not utilized to measure the cuts so an evaluation of over or under resected surfaces cannot be performed in the log review.The most probable root cause for the issue could not be determined.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review: due to positive service history, dhr review only covers the related service records.Service history record review result is not relevant to the current complaint.

• Brand Name: VELYS SATELLITE STATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24670224
• Report Number: 1818910-2026-05023
• Device Sequence Number: 20097520
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: (01)10603295519492(10)SAT1338
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 451570101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown