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

Model Number 4515-70-011

Device Problem Unintended Movement (3026)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4), email received on 23-september-2022 from the reporter with additional event information.The reporter stated that "i didn¿t see the array move, we needed to move the robot back into position and finish the cuts.Patient was not affected by the short delay.We finished the surgery successfully.No more information is available.This is now the 3rd time this has happened, hopefully the update remedied the issue." 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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Problem reported: (b)(6) reported that the system reported that the device array moved in the middle of surgery.They did not bump, hit or otherwise move the system beyond the robot moving to the next cut when this issue occurred.There were no negative impacts to the patient.The fse will be on-site today to do the software upgrade so they are asking if the system can be looked at.See complaint (b)(4) for the work orders for service, (b)(4).When was the issue observed? during surgery.Time and date of surgery? (b)(6) 2022.What step were they on when this issue occurred? anterior chamfer.Troubleshooting: they were able to get the device array back into the original position and were able to complete the surgery without any further issue.If issue with cuts is reported, is robot mounted to the bed? unknown patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? no are patient treatments delayed or cancelled? no.Next day of surgery: (b)(6) 2022.All information has been disclosed.No further information was provided.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot
=
> a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15549816
• MDR Text Key: 301481149
• Report Number: 1818910-2022-19631
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295520146
• UDI-Public: 10603295520146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4515-70-011
• Device Catalogue Number: 451570011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• 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