MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VELYS NAVIGATION STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451611000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.H6: investigation summary: there were three issues identified on (b)(4).Issue #1a - customer reported spin with co system which cut off anterior portions of the bodies.Issue #1b - when instrumenting screws with the cut off anterior portions, this cut off the count down of the measurements to the distal tip.Issue #2 - deviated screw the l4 right screw.Issue 1a: the investigation confirmed "customer reported spin with co system which cut off anterior portions of the bodies.Trying to instrument screws.Cut off the count down of the measurements to the distal tip.".The investigation was conducted by the r&d team.The log files were reviewed and investigated by the r&d team.The investigation showed that the patient 3d image was not large enough to include both the phantom and the whole vertebra bodies, due to patient's high bmi and limited field of view of the imaging system.Only partial vertebra bodies were visible in the 3d image, leading to the target screws being planned with their tip outside the 3d image.The user indicated that there was no negative impact to the patient outcome and no patient harm.Issue 1b: the investigation confirmed "customer reported spin with co system which cut off anterior portions of the bodies.Trying to instrument screws.Cut off the count down of the measurements to the distal tip.".The investigation was conducted by the software r&d team, during the log file review it was confirmed that the screws were planned outside the 3d volume and when the instruments were navigated near the end of the planned screws, the widget indicating the instrument tip to planned screw tip distance (instrument depth indicator) became occluded.The widget location computation presupposes that the planned target tip would be in the 3d image, which was not the case, the label ended up being hidden.The velys active robotic assistance for spine ifu rev c (ifu-090260229) states that the "phantom should be positioned so that patient¿s anatomy, region of interest, and radiopaque fiducials can be visible in both frontal and sagittal imaging views".The use error described in issue 1a, lead to the reported display failure.When functioning within the specifications of the ifu, the instrument depth indicator was placed where it was expected to be displayed.There were no defects found with the software when operating within conditions specified in the ifu.Based on the investigation findings, an improvement of the software is proposed to display of the instrument depth indicator even when the screw tip is planned outside the acquired 3d volume.This improvement is intended to be part of the next software release.This software issue has been addressed in a non-conformance.The user indicated that there was no negative impact to the patient outcome and no patient harm.Issue 2: the investigation confirmed "second issue was a deviated screw the l4 right screw".The investigation was conducted by the r&d team.The device was not returned to depuy synthes for evaluation, and was deemed working per specifications.The investigation showed that the correct log file was identified and that screw deviation occurred during l4 right screw placement.Based on the review and analysis of log files, and following user feedback, the most probable cause of the reported issue is skiving.There were no defects found with the software, the device behaved as expected.Information regarding the trajectory inaccuracy when compared to the planning were displayed to the user.The user decided to proceed.The hypothesis here is to assume that the user did not take into account the information displayed by the device.The user stated that the screw placement was clinically safe.The user indicated that there was no negative impact to the patient outcome and no patient harm.Root cause: issue 1a: customer reported spin with co system which cut off anterior portions of the bodies.Based on the review and analysis of log files, the most probable cause is use related due to patient's high bmi and limited field of view of the imaging system issue 1b: customer reported cut off of the count down of the measurements to the distal tip.Based on the review and analysis of log files, the 3d image used did not include the anatomy and region of interested as specified in the ifu.This use case outside the ifu lead to an issue of the display of the instrument depth indicator.When functioning within the specifications of the ifu, the instrument depth indicator was placed where it was expected to be displayed.There were no defects found with the software when operating within conditions specified in the ifu.Issue 2: second issue was a deviated screw the l4 right screw.Based on the review and analysis of log files, the most probable cause is a soft tissue conflict or a skiving.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot device history review for 451611000/(b)(6): manufacturing date: 26-jun-2025 the device has not been previously serviced.Device history record shows that sn: (b)(6) of 451611000 was processed through the normal installation and inspection operations with no rework or nonconformities noted.Serial no: (b)(6) met all required criteria at the time of release with no issues documented during the installation process.Review of the device history record(s) showed that there were no issues during the installation of this product which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during the surgery the spin with co system which cut off anterior portions of the bodies.Trying to instrument screws.Cut off the count down of the measurements to the distal tip.Second issue was a deviated screw the l4 right screw.Troubleshooting: still within parameters but excessive pressure warning.Put the driver in and deviated by a couple millimeters.Still clinically safe.Fse support requested to pull logs and evaluate issues.There were no reports of injuries, medical intervention or prolonged hospitalization and patient treatment was no delayed or cancelled due to reported issue.No further information was provided.

• Brand Name: VELYS NAVIGATION STATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22978819
• Report Number: 1526439-2025-01128
• Device Sequence Number: 9540772
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K233228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 451611000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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