MAUDE Adverse Event Report: DEPUY IRELAND 9616671 VELYS SATELLITE STATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 4515-70-101

Device Problem Positioning Failure (1158)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.The device serial or lot number was unknown; therefore, udi: (b)(4), unknown.The manufacturing location is unknown.Device manufacture date is unknown.The device serial or lot number is unknown concomitant medical devices and therapy dates, robotic assisted base station device and robotic assisted saw handpiece device broach adaptor device, (b)(6) 2021.

Event Description

It was reported during a surgical procedure, it was observed that "some cuts" would be off by as much as 3mm on the robotic-assisted solution satellite station.It was further reported that the doctor noticed that the cuts ¿would be off", and therefore no further cuts were made with the device and the procedures were finished with manual instrumentation.It was reported that the device was being used with a robotic assisted base station and a robotic assisted saw handpiece device.It was not reported if there were any delays in the surgical procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization reported.

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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.D4: the device serial number was reported as unknown in the initial report and has been updated accordingly.The device udi has also been updated.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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: the actual device was returned for evaluation.During evaluation it was determined that the reported issue that all cuts were being reported as 3mm off was due to user error during the use of the system.The system was visually examined and functionally checked and no issues or anomalies were found.Additionally, a sawbone study was performed to assess the operation and accuracy of the system and found that the system was operating properly and accurately.The saw handpiece was returned and further evaluated.No defects or issues were found with the saw handpiece used in the case.A saw bone study was conducted on the returned system and a 3mm distal resection error could not be replicated and no defects or anomalies were found with the system.The system was operating properly and accurately.An analysis of the log files was performed and analysis of the replay of the posterior cut that was simulated from the log files identified that the sawblade skived and the sawblade did not enter the bone and therefore the cut could not be executed.Through on-site investigation and discussion of the case with the surgeon team present during the procedure, it was identified that the surgeon was attempting to cut large hard bone.It was also noted by an individual that was present during the procedure that prior to beginning the posterior resection, the sawblade was observed to have a significant amount of bony build-up in the teeth of the sawblade.No defects or issues were found with the software, saw handpiece or system and it was determined the system was operating properly and accurately.The distal resection error could not be replicated on the returned system.Analysis of the log files in indicated that the saw blade skived.Discussion of the case with the surgeon team present during the procedure indicated that the surgeon was attempting to cut large hard bone and that prior to beginning the posterior resection, the saw blade was observed to have a significant amount of bony build-up in the teeth of the saw blade.The assignable root cause was determined to be due to improper handling/user.

• Brand Name: VELYS SATELLITE STATION
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12959632
• MDR Text Key: 287007435
• Report Number: 1818910-2021-27456
• 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: Z12130401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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