MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02000

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Event Description

It was reported that during a navio tka procedure, the femur was disoriented on the screen and upside down.They rebooted and re-stated the case with a delay of less than 30 minutes.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio surgical system us, pn: npfs02000, (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, and the navio surgical system log files and/or case files were not provided.Therefore visual and functional inspections and log/case file assessments could not be performed, and the reported problem could not be confirmed.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.Other than a possible software bug, no reasonable contributing factors could be identified based on the received complaint information.No containment or corrective actions are recommended at this time.If the system log or case log associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10655551
• MDR Text Key: 210622866
• Report Number: 3010266064-2020-01830
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NDI CAMERA POLARIS SPECTRA (PFSR200027); PFSR200027; UNKN NAVIO ROBOTICS INSTR; PFSR200027