MAUDE Adverse Event Report: DEPUY IRELAND UC VELYS BASE STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-100

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Udi:(b)(4).Device manufacture date is unknown.The device serial or lot number is unknown.

Event Description

It was reported that the robot assisted base station device had an electrical short in the cable.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2022.All available information has been disclosed.If additional information should become available, a supplemental report 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.The described failure by the customer was confirmed.Root cause summary: based on the event description, and engineering review the root cause can be determined, to be related to a the robot cable.Which was confirmed, to have an intermittent unintentional short.This issue has been escalated to a capa.Review of the device records, indicates that there were no issues, during the installation of this product.Which, would contribute to this complaint condition.The assignable root cause was determined to be, due to design.

• Brand Name: VELYS BASE STATION
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND UC; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: amy hendrickson ; 700 orthpaedic dr.; warsaw, IN 46581 ; 5743674841
• MDR Report Key: 14024541
• MDR Text Key: 288695994
• Report Number: 1818910-2022-05756
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519515
• UDI-Public: 10603295519515
• Combination Product (y/n): N
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-100
• Device Catalogue Number: 451570100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1