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

Model Number NPFS02000

Device Problems Application Program Problem (2880); Insufficient Information (3190)

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

Event Date 11/12/2019

Event Type  Injury  

Event Description

It was reported that representative and surgeon noticed the femoral implant was placed on the bony surface and it had an extreme medial shift.Rep had the surgeon repaint the femur which did not take care of the implant placement.The rep restarted the case to re-collect landmarks and a delay greater than 30 minutes was reported.

Manufacturer Narrative

H10: a1, d10, e4, h3: updated information.H11: b1, b2, g3, g5, h1, h6: corrected information.

Manufacturer Narrative

H10: the device was used in treatment.Device history record review found that the software version has been validated.A complaint history review found similar reports, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The navio system instructions for use released at the time of the complaint provides instructions for troubleshooting and usage of the device.While case log files and screenshots were returned, the log files attached to the complaint depict an error with malleoli collection, not a medial shift in the implant.Therefore, the log files associated with the case were not returned and visual and functional inspection could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to the reported issue includes if there was an issue with the implant placement algorithm if one of the distal condyles is more distal than the other by more than the thickness of the implant, then there is resection on one condyle only and the implant centers itself on.No further medical assessment is warranted at this 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: 9433993
• MDR Text Key: 188489552
• Report Number: 3010266064-2019-00139
• 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,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: ORNPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other