MAUDE Adverse Event Report: Medos International SÃ rl CH VELYS ROBOTIC-ASSIST STATION; Orthopedic stereotaxic instrument

Catalog Number	451611001
Medical Device Problem Codes	Mechanical Problem (1384); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an excessive amount of joints clicking through out the case that resulted in temporary arm delays.Robot on patient right.There were no reports of injuries, medical intervention or prolonged hospitalization.No further information was provided.
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.Additional narrative: h3, h6: investigation summary: the investigation confirmed multiple temporary arm issues occurred during the case.The investigation of log files by the r&d team.The investigation showed that the correct log file was identified.The investigation showed that the robotic arm applied brakes unexpectedly during dynamic compensation.Brake activation produces a clicking sound in the robot joints, which is consistent with the allegation of "excessive amount of joints clicking".13 instances of the pop-up which appears during a dynamic compensation motion was confirmed through the log review.The user reported that there was no adverse effect on the patient¿s outcome, no harm to the patient, and no further medical intervention was needed.Root cause: there is a software issue in the supplied robotic arm controller that can lead to this error condition during dynamic compensation.Further investigation and assessment are addressed within our quality management system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VELYS ROBOTIC-ASSIST 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 ; +1(908)386-3534
• MDR Report Key: 50791620
• Report Number: 1526439-2026-01456
• Device Sequence Number: 10515783
• Product Code: OLO
• UDI-Device Identifier: 10705034646008
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• 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: 451611001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008114965-07/16/2026-00
• Patient Sequence Number: 1
• Patient Sex: Unknown