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

Catalog Number	451611000
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this was a spine robotic case for l1-s2.During the procedure they moved to s2 the tool holder was violating the safety box of the phantom.It then violated safety box during every trajectory.When sending it to next trajectory the robot collided with the patient.Troubleshooting included: shutdown the robot station and restarted.Completed brake test before proceeding.They were able to complete the case however, the system continued to violate the safety box.Setting up ct image before hand there were no issues they attached the patient array to l1 and the phantom array over the operation area.Patient was average size.Robot collided with patient near the t12 area (rib) left side of the patient.There was a surgical delay of 10-15 minutes.The patient has potential bruising as the robot collided with the patient.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: h3, h6 investigation summary: according to the information received, the issue with the following product: 451611000, sn: (b)(6).Customer reported during a spine robotic case l1-s2, during the procedure they moved to s2 the tool holder was violating the safety box of the phantom.Violated safety box during every trajectory.Sending it to next trajectory the robot collided with the patient.Investigation summary: three issues were investigated: issue 1: customer reported during a spine robotic case.L1-s2 during the procedure they moved to s2 the tool holder was violating the safety box of the phantom.Violated safety box during every trajectory.Issue 2: sending it to next trajectory the robot collided with the patient.Issue 3: further log review investigation is under velys robotic-assist station.Issue 1: customer reported during a spine robotic case.L1-s2 during the procedure they moved to s2 the tool holder was violating the safety box of the phantom.Violated safety box during every trajectory.The feature described as a "safety box" in the reported complaint is not a feature of the system.The investigation team is interpreting the "safety box" that is being referred to as the scp (skin contact plane).This is a computational tool used to compute trajectories.It is not a safety box in the sense that the tool holder may enter this zone, by current algorithm design.The log files were reviewed and investigated by the r&d team.Photo activities confirmed the investigation.The investigation showed that the tool holder was going below the patient and table interference volume (also known as scp - skin contact plane).The tool holder entering the scp is expected behavior, the computed trajectory can, under certain conditions, go below the patient and table exclusion zones.Based on the review and analysis of log files, the software behaved as expected - no defect found : the tool holder is allowed to go below the patient and table interference volume (also known as scp - skin contact plane).There were no defects found with the software.The user indicated that there was no negative impact to the patient outcome and no patient harm.Issue 2: sending it to next trajectory the robot collided with the patient.The investigation confirmed "sending it to next trajectory the robot collided with the patient." the log files were reviewed and investigated by the r&d team.Each of the joint positions elected for the joint path do not violate the sdp (safe distance plane).The alignment algorithm is not able to detect potential collisions between the elected joint positions.The ifu includes a warning to the user for the motion to remain under strict control of the surgeon and be stopped if there is a potential collision (per ifu warning on page 188."any robotic arm movement should remain under strict control of the surgeon.If any potential collision is detected, stop motion by releasing ¿footswitch¿ or ¿multifunction¿ buttons.Manual arm manipulation can be used to move away the robotic arm.").There were no defects found with the software.The user indicated a potential bruising could have occur however there was no actual bruising reported.Root cause: issue 1: based on the review and analysis of log files, the software behaved as expected - no defect was found.The tool holder is allowed to go below the patient and table interference volume (also known as scp - skin contact plane).Issue 2: based on the review and analysis of log files, no defect was found in the elected joint path of the robotic arm.One possible cause of the reported issue could be use related.The robotic arm made unintended contact with patient outside of the surgical incision under activation of the actuator and supervision of the surgeon.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review: no manufacturing record evaluation required as no manufacturer or service related issue found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22861033
• Report Number: 1526439-2025-01081
• Device Sequence Number: 15386797
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup

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): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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