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

Model Number 4515-70-101

Device Problems Connection Problem (2900); Appropriate Term/Code Not Available (3191)

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

Event Date 06/24/2022

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.Additional narrative: the actual device was returned for evaluation.During repair, an analysis of the returned photos the reported condition was confirmed.It was further determined that the device cable had damage and was found to have had the label removed from one of the cable plugs and placed over the existing label of the other one.The assignable root cause for the damage is user error due to improperly plugging the cable into the wrong socket.The most assignable root cause for the labeling issue is device adulteration.Udi: (b)(4).

Event Description

It was reported that during case setup and component connection initialization, the robotic assisted satellite station device indicted that all of the lines were green but had a persistent message "saw not connected".During an in-house engineering evaluation, it was determined that the device had cable damage and it was also found that the cable had a label removed from one of the cable plugs and placed over the existing label of the other one.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 the 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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: VELYS SATELLITE STATION
• 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: 15274735
• MDR Text Key: 304976692
• Report Number: 1818910-2022-16357
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10603295519492
• UDI-Public: 10603295519492
• 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: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4515-70-101
• Device Catalogue Number: 451570101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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