MAUDE Adverse Event Report: DEPUY IRELAND VELYS SAW HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 451570102

Device Problems Unintended System Motion (1430); Intermittent Loss of Power (4016)

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

Event Date 07/14/2023

Event Type  malfunction  

Event Description

It was reported that during a total knee arthroplasty procedure, it was observed that while using the robotic-assisted saw handpiece device the surgeon stopped after starting to make the first cut because there was some cut out.It was reported that the surgeon pulled away from the bone and did not have his finger on the saw trigger.It was reported that the saw slowly fired the blade back and forth with no trigger pulled for about 5 seconds.It was reported that they proceeded with the cut and did not experience this anymore though the rest of the case.The device was being used with a base station device and a satellite station device.There were no delays in the procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.D4, h4: the device serial/lot number and date of manufacture are unknown at this time.D10, concomitant medical devices and therapy dates, base station device, satellite station device (b)(6) 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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

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: d4, h4: the device serial/lot number and manufacture date were unknown in the initial report and have been updated accordingly.The device udi has also been updated.(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.Investigation summary: results received from the engineering team: the actual device was returned for evaluation.During evaluation it was found that the reported issue could not be confirmed and the device system passed all onsite testing.Evaluation of the handpiece found that the device failed the speed test (saw blade deflection) as well as vibration.There was also bearing damage reported.However, the reported issue was still unable to be replicated.Based on the lack of replication and inconclusive log data, this complaint could not be confirmed.The assignable root cause was determined to be due to normal wear.

• Brand Name: VELYS SAW HANDPIECE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17398138
• MDR Text Key: 320154758
• Report Number: 1818910-2023-15271
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519430
• UDI-Public: 10603295519430
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/26/2023

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 Catalogue Number: 451570102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/01/2023; 08/29/2023; 10/20/2023; 10/20/2023
• Supplement Dates FDA Received: 08/03/2023; 08/31/2023; 10/23/2023; 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1