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

Catalog Number 110137

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 03/22/2019

Event Type  Injury  

Event Description

It was reported that there was an error on bootup.Error code: 40000000000."an error occurred during initialization.Pfs control hardware failure (errcode = 40000000000).Please contact robotics customer support to solve this issue".The intended surgery was performed in a conventional way.The patient outcome is unknown.

Manufacturer Narrative

H10: h3, h6: the device, intended for use during 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: 9994063
• MDR Text Key: 189344212
• Report Number: 3010266064-2020-01010
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• 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: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 220025
• Patient Outcome(s): Hospitalization; Required Intervention