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

Catalog Number 220025

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 01/23/2014

Event Type  Injury  

Event Description

It was reported that during procedure, message appeared when surgeon was just about to start cutting.After several attempts to re-initialize the hardware without success, decision was taken to revert to manual implantation.("warning.Usb cable unplugged.Plug everything back in and press dismiss again to re-initialize the hardware").

Manufacturer Narrative

The device, used during treatment, was returned for a prior investigation and was discarded.There was no serial number provided for dhr review 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 (b)(4).Instructions on preventative maintenance on the navio surgical system in the event that service is needed.This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.The initial functional investigation was performed finding that the system logs shows error code -32 due to a defective dual coil.The root cause of the reported event was due to a design fault.

• 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: 9996809
• MDR Text Key: 188869989
• Report Number: 3010266064-2020-00144
• 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: 08/21/2020

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?: No
• Device Operator: No Information
• Device Catalogue Number: 220025
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1