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

Catalog Number NPFS02000

Device Problem Poor Quality Image (1408)

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

Event Date 03/16/2018

Event Type  Injury  

Event Description

It was reported that during the bur phase of tka, the drill would not work in speed control but did in manual mode.Doctor continued in manual mode, however when burring, the post holes would not show the bone model being resected away and didn't know how deep to bur.In addition, the lower left birdseye view of the bone was extremely zoomed in and pixelated, causing doctor to not be able to use it as a reference in conjunction with the cross hairs/targets to align the bur.Used the visualization tool to check that if it was still in line with the plan.

Manufacturer Narrative

\ the navio surgical system was used in treatment and case log files and screenshots were returned for evaluation.Dhr review found that the software version (navio 5.2) has been validated.A complaint history review found no similar reports, as the 1 complaint in the review is this complaint, and this issue will continue to be monitored.The navio surgical system: surgical technique for total knee arthroplasty was reviewed and it has information regarding proper positioning of exposure control guard.Additionally, product labeling has been ruled out as a cause of the complaint.This failure is captured in the navio risk profile.The navio surgical system logs were returned for evaluation and an initial visual inspection confirmed the reported problem.Review of the log files found that it was not a software issue.The bird's eye view became pixelated because the view is determined by the location of the guard.Since the guard was lower than where it usually would be, the bird's eye view showed to be very close to the bone, resulting in the pixelated appearance.The root cause of this issue was determined to be user error.

• 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
• MDR Report Key: 9998175
• MDR Text Key: 189448802
• Report Number: 3010266064-2020-00815
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR