MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SIU - 220025; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 220011

Device Problem Image Display Error/Artifact (1304)

Patient Problem Injury (2348)

Event Date 07/27/2018

Event Type  Injury  

Event Description

It was reported that during a surgical procedure, a "handpiece exposure control motor failure" warning appeared multiple times when at the point of pressing cut femur on the burring screen.Handpiece continued to pass validation and homing steps which had to do multiple times to stay in the workflow.A second handpiece was opened and set up with the same result.For the exercise, a second drill was set up as well.No clamps were used on the cables thus broken cables not an issue.The surgeon decided to use manual instrumentation, no patient injuries reported beyond this event.Results of investigation have concluded that there was an over current error that was caused by the siu, there was no problem found with the handpiece.The over current failure is a problem in the siu that randomly causes handpiece disconnect errors, which makes it a reportable event.

Manufacturer Narrative

H10 h3, h6: the device was used during treatment but only the log files were returned for a prior investigation.The initial visual evaluation was performed by reviewing the returned log files which found that an "over current" error had occurred.When the error can only be cleared by rebooting the system, it is indicative of an issue in the siu firmware that randomly causes the handpiece error message and is not indicative of an issue with the handpiece.The errors occurred on two different handpieces and therefore this confirms the issue in the siu.There was no serial number provided for the dhr review of the siu so it could not be concluded if the device met the manufacturing specifications.A complaint history review found similar reports of the issue.This issue will continue to be monitored.The surgical technique guide released at the time of the complaint provide instructions troubleshooting information on the navio surgical system.This failure has been captured in the risk profile.The relationship of the device and the reported event has been established.The over current error that occurred was due to an issue in the siu.As a result, the root cause of the reported event was due to an electrical component failure.

• Brand Name: SIU - 220025
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9997217
• MDR Text Key: 188882297
• Report Number: 3010266064-2020-00684
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 220011
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANSPACH DRILL.; NAVIO HANDPIECE.; ANSPACH DRILL; NAVIO HANDPIECE
• Patient Outcome(s): Other; Required Intervention