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

Model Number NPFS02000

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that malleoli collection error was received.Doctor recollected registration points and re-collected neutral position with less hip flexion (the leg more parallel to the bed) and the error cleared.Delay of less than 30 minutes and no patient injuries reported.

Manufacturer Narrative

The device was being used during treatment when the screen had an error message.The log files nor any case screenshots were not returned for evaluation.The software version was not recorded, but dhr review shows that all navio software versions released to the field a factor that could have contributed to the reported issue is if the malleoli were collected in the incorrect order or if there was a software failure.Have been validated.A complaint history review was performed and found 179 reports of the issue.This issue will continue to be monitored.A relationship between the device and reported event has not been established.Without the actual log files or case screenshots, the issue could not be confirmed.A factor that could have contributed to the reported issue is if the malleoli were collected in the incorrect order or if there was a software failure.The root cause of the reported event could not be determined.If the log files or case screenshots are returned, the complaint will be re-investigated at that time.

• 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: 9999426
• MDR Text Key: 189063201
• Report Number: 3010266064-2020-01432
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR