MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 VELYS ARRAY SET KNEE; ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY

Model Number 4515-70-011

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthese for evaluation, however a photo and log files were available for review.Review of the photo and log files confirmed the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.

Event Description

It was reported that on (b)(6) 2023, the patient underwent the tka surgery with vras.In the surgery, the event with the velys base station in question took place in sequence as follows: the surgeon operated at femur first.Osteotomy up to the front of the femur was performed without problems.During the posterior osteotomy, there was a phenomenon in which the robot arm and handpiece floated.Since it was a one-time phenomenon, the operation was continued.As a result, the osteotomy was much larger than planned, and an error screen was displayed after that, so he stopped using the robot.The severely cut bone was fixed with fixsorb and a primary implant was used.The surgery was completed successfully without any surgical delay.No further information is available.

• Brand Name: VELYS ARRAY SET KNEE
• Type of Device: ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16642418
• MDR Text Key: 313306042
• Report Number: 1818910-2023-06954
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: 10603295520146
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2023

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
• Device Operator: Health Professional
• Device Model Number: 4515-70-011
• Device Catalogue Number: 451570011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1