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

Catalog Number 451570106

Device Problems Device Slipped (1584); Vibration (1674)

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

Event Date 01/01/2023

Event Type  malfunction  

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 and saw interface device, september 12, 2023.Udi: (b)(4).

Event Description

This is report 2 of 2 for the same event.It was reported that during a total knee arthroplasty surgical procedure, it was observed that while using the robotic assisted saw interface right (sasi) and the robotic assisted saw handpiece device it was reported that the housing of the saw was loose and there was a lot of vibration.It was reported that as a result, the cuts were over resected by 2mm.It was reported that this occurred on the last 3-4 knees.It was reported that they do not believe it is the same saw or sasi in each event as they have multiple sets.It was reported that the device was also being used with a robotic assisted satellite station device and a base station device.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: VELYS SAW INTERFACE RIGHT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46581
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17756153
• MDR Text Key: 323510763
• Report Number: 1818910-2023-18858
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519478
• UDI-Public: 10603295519478
• 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
• Report Date: 09/15/2023

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: 451570106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1