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	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Case code: (b)(6).It was reported that it was a l3-l4-l5 plif procedure, screw placement in zig-zag pattern, starting with l3 left and ending with l5 right.Two doctors operated during the procedure, one on the left side and the other on the right.They did an anatomy check at the beginning of the procedure.It was navigation only procedure.There were multiple issues reported during the case: 1.Number 1 array was not recognized by the system.The camera saw all 4 orbs but it didn't recognize it as the array.They were able to continue using the array through the procedure by moving the camera.2.L4 right screw was in the disc space and was found during the discectomy.This screw was the only screw placed with power during the procedure.3.L5 left screw was high and outside after initial placement.L5 right screw was placed in the planned position.Troubleshooting: they did a second spin after the l5 right screw was placed and replaced the l4 right and l5 left screws using navigation.They were placed as was planned.There were no reports of injuries, medical intervention or prolonged hospitalization.Patient treatments were not delayed or cancelled all information has been disclosed.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.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: sn (b)(6), sn (b)(6).Case code: (b)(4), l3-l4-l5 plif procedure.Screw placement in zig-zag pattern, starting with l3 left and ending with l5 right.Two doctors operated during the procedure, one on the left side and the other on the right.They did an anatomy check at the beginning of the procedure but it was not very in depth according to the rep.There were multiple issues reported during the case: 1.#1 array was not recognized by the system.The camera saw all 4 orbs but it didn't recognize it as the array.They were able to continue using the array through the procedure by moving the camera.2.L4 right screw was in the disc space and was found during the discectomy.This screw was the only screw placed with power during the procedure.3.L5 left screw was high and outside after initial placement.L5 right screw was placed in the planned position.Investigation summary: there were three issues reported.Issue 1: the investigation confirmed "#1 array was not recognized by the system.The camera saw all 4 orbs but it didn't recognize it as the array.They were able to continue using the array through the procedure by moving the camera." the investigation was conducted by the r&d team.The velys spine array base set (p/n 451611021, lot au81794613) was returned to depuy synthes for evaluation.No obvious visual defects were found on instrument array 1.In addition, log files as well as device history records were reviewed and investigated by the r&d team.The investigation showed that the correct log file was identified and that the instrument array 1 was flickering or being not visible during the end of the navigation step.As a result of the review of log files, the determined cause of the reported visibility issue is the trigger of a visibility filter built in velys spine system protecting the system accuracy.This trigger is linked to soil (blood) on the spheres altering their visibility.There were no defects found with the array and software.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.Capa is opened to monitor the subject.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Issue 2 & 3: the investigation partially confirmed the allegation screws misplacement.The investigation was conducted by tpm team.The investigation showed that the correct log file was identified.The were no defects found with the device, and logs confirmed the device monitored registration mismatch, but user elected to proceed with insufficient anatomy check.The user indicated that there was no negative impact to the patient outcome and no patient harm.Root cause: issue 1: based on the review, the determined cause is a use error.Issue 2 & 3: based on the review, the most probable cause is a use error.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.If information is obtained that was not available for the initial report, a follow-up report 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 33410
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23544865
• Report Number: 1526439-2025-01497
• Device Sequence Number: 21276116
• Product Code: OLO
• UDI-Device Identifier: 10705034645995
• UDI-Public: (01)10705034645995
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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