MAUDE Adverse Event Report: DEPUY IRELAND VELYS ARRAY CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 451570107

Device Problem Device Slipped (1584)

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

Event Date 04/04/2024

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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 devices and therapy dates, base station device, (b)(6) 2024.Udi: (b)(4).

Event Description

It was reported that during a total knee arthroplasty surgical procedure, it was observed that the two (x2) robotic assisted array clamp devices were being used when the arrays moved.It was reported that the device was being used with 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.This is report 1 of 2 for (b)(4).

• Brand Name: VELYS ARRAY CLAMP
• 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19091711
• MDR Text Key: 340508999
• Report Number: 1818910-2024-08141
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519379
• UDI-Public: 10603295519379
• 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: 04/11/2024

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: 451570107
• Device Lot Number: J47239
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1