MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 110137

Device Problem Failure to Calibrate (2440)

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

Event Date 12/11/2018

Event Type  Injury  

Event Description

It was reported that, during set up for a case, the handpiece did not calibrate forcing an error to pop up.The system was rebooted per error and then integrity test error 40000000000 came up.Navio was aborted and case was completed with manual instruments.The patient outcome is unknown.The result of investigation indicate that the damaged cord caused a short circuit that blew a fuse in the siu, which is a reportable malfunction.

Manufacturer Narrative

H10: h3, h6.The device, intended for use in treatment, was returned for investigation.The initial evaluation of the handpiece found that there was short in the cabling.The dhr was reviewed and the product met manufacturing specifications.A complaint history review found similar complaints of the reported issues and will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable, etc.Since the issue was due to component failure, product labeling has been ruled out as a cause of the complaint.This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.The short in the handpiece cabling caused the blown fuse in the siu.The root cause of the reported event was due to electrical component failure.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9994102
• MDR Text Key: 189345434
• Report Number: 3010266064-2020-00756
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110137
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIU - 220025
• Patient Outcome(s): Required Intervention