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

Catalog Number 220025

Device Problem Failure to Calibrate (2440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2016

Event Type  Injury  

Event Description

It was reported that, during an ukr surgery, the system displayed a handpiece error failure.The error indicated that there were 3 potential issues: 1.Handpiece jam, 2.Battery issues, 3.System failure.After dismissing the error, the system jumped back to the initial handpiece connection screen.The drill and the handpiece were checked; then, recalibration was attempted, but the handpiece did not home.The handpiece gears could not be manually moved when checked.The system recalibrated but would not home.When opening the handpiece to check the small gears, they could not be moved.While troubleshooting, the surgeon decided to manually cut the tibia.A second handpiece was used for the rest of the surgery.Surgery was delayed about 5 min.The patient outcome is unknown.

Manufacturer Narrative

H10 h3, h6: the device, used in treatment, was not returned for evaluation.The relationship of the device and the reported event has been established.The root cause of the reported event was due to an electrical component failure.The initial visual investigation was performed by reviewing the returned log files which found that an "following error had occurred during cutting.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 a similar report 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 to provide solutions for the most common problems.

• Brand Name: SIU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; ste 40; plymouth, mn
• MDR Report Key: 9997589
• MDR Text Key: 188891987
• Report Number: 3010266064-2020-00299
• 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
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 220025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR