MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VELYS¿ ROBOTIC-ASSIST STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451611001
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during screw placement in a spinal procedure, the l4 right screw was slightly lateral from plan due to screwdriver hitting the retractor and due to screw release mode.Screw position was confirmed by o-arm spin.3d imaging was used.Just one portion of the screw trajectory was lateral.The screwdriver collided with the end of the self retaining retractor, which altered the trajectory.Screw release/actie mode was attempting to redirect screw back to original position mid-insertion due to deflection by retractor.User removed screw and placed with free-hand navigation.There was no report of injury, medical intervention or prolonged hospitalization.There was a minimal delay due to the event.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h6: investigation summary: according to the information received, the issue with the following product: 451611001 sn (b)(6).During screw placement, l4 right screw was slightly lateral from plan due to screwdriver hitting the retractor and due to screw release mode.Investigation summary: the investigation confirmed anatomical conflict occurred during the procedure.The investigation was conducted by tpm team.The investigation showed that the correct log file was identified.Based on the review and analysis of log files, the most probable cause of the reported issue is an anatomical conflict in between l4 spinous process and l4 right screwhead.The displayed message when the conflict has been detected is described in the device ifu: p.253 - appendix3: device troubleshooting ¿red header: "realigning to target" keep adaptive tracking activated until tool holder realigned with target.Header must turn green before proceeding with navigated instruments.Manual arm manipulation mode is available to help release excessive forces if necessary.Once the forces are released, realign the robotic arm to the target.¿ it is also globally recommended to avoid soft tissue, or any other kind of, pressure p.170 ¿ implant and disc access selection and positioning ¿screw planning recommendations open procedure: be mindful of soft-tissue pressure.It is recommended that open screws are planned with an angulation off midline less than or equal to 12 degrees.Bi-lateral retraction only.Where possible, 90° angles to the bone surface are recommended to avoid inaccuracies or skiving.¿ there was no indication of device malfunction.Based on the investigation findings, no corrective and/or preventive action is proposed.The user indicated that there was no negative impact to the patient outcome and no patient harm.Root cause: an anatomical conflict, visible during intra-operative planning, has led to screw deviation.The velys active robotic assistance system for spine does not appear to be at fault.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): 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¿ 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
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22817913
• Report Number: 1526439-2025-00951
• Device Sequence Number: 5713407
• Product Code: OLO
• UDI-Device Identifier: 10705034646008
• UDI-Public: (01)10705034646008
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Physician
• 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: 451611001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VELYS CAMERA STATION
• Patient Sex: Unknown