MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW INTERFACE LEFT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-105

Device Problems Appropriate Term/Code Not Available (3191); Premature Separation (4045)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

It was reported during a total knee arthroplasty procedure, it was observed that while using the robotic-assisted solution satellite station device and base station device the system terminated the application.It was seen on the screen that there was a "system console error" but the user was unable to get an error code.It was reported that this occurred during the anterior chamfer cut.The reporter stated that when the robotic assisted saw interface device (sasi) was checked, it was observed that it had opened up during the procedure.It was reported that the sasi lever was not loose when the saw was installed.It was reported that they transitioned to manual instrumentation so there was no negative impact to the patient.It was reported that there were no delays in the surgical procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization reported.

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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant medical products:concomitant medical devices and therapy dates, robotic assisted satellite station device and base station device, june 5, 2023.Udi: (b)(4).

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.H10 additional narrative: the device was not returned for evaluation.Therefore, an evaluation of the device could not be performed.A manufacturing record evaluation (nc search) was performed for the finished device and no non-conformances / manufacturing irregularities were identified and were manufactured, inspected, and distributed to approved specifications.

• Brand Name: VELYS SAW INTERFACE LEFT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17162043
• MDR Text Key: 317510997
• Report Number: 1818910-2023-12391
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519461
• UDI-Public: 10603295519461
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-105
• Device Catalogue Number: 451570105
• Device Lot Number: J46130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1