MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 VELYS ARRAY SET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	451570001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the array came loose on velys saw during tibia cut, and swung out.Nurse may not have clicked it in properly and missed by rep and surgeon.Tibia resection mostly within plan, however posteriolater tibia was over resected (according to velys by 2-3mm) recalibrated saw and saw blade.Rest of case completed successfully, all 4 femur cuts accurate.Planned to use cementless tibia - however used cemented implants instead because of inaccurate cut surgery delayed 5 minutes due to the reported event.
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
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The product was not returned to depuy synthes; however, photos were provided for review.Additionally, the investigation was performed by the software and systems team via review of the log files for the procedure.Review of the photographic evidence shows inconsistent cuts in the tibial bone, confirming the reported allegation.However, the millimeters of resection cannot be determined from a photograph.Based on the available information and the fact that the device was not returned for further functional testing, the root cause of the reported complaint condition is not suspected to be a design or manufacturing issue.Additionally, the results of the log files review revelated that the system is performing as intended and therefore a root cause cannot be determined with a single assignable cause.

• Brand Name: VELYS ARRAY SET
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19049123
• Report Number: 1818910-2024-07612
• Device Sequence Number: 12882437
• Product Code: OLO
• UDI-Device Identifier: 10603295519072
• UDI-Public: 10603295519072
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 451570001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown