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

Catalog Number NPFS02000

Device Problem Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

It was reported that while using a demo system on a cadaver used the pfj application.The implant was planned too proud laterally, but kept that way to show doctor why plan was off.The size and position planned fit what was cut.However, there was excess bone that was resected anteriorly (up into the long bone).

Manufacturer Narrative

H10 h3, h6: the device was intended to be used in treatment and the location of the pfj implant shown in the navio screens was not as expected in comparison with where the pointer probe tip was showing on the screen versus the location on the actual anatomy.The software version was not recorded, but dhr review shows that all navio software versions released to the field have been validated.A complaint history review identified similar events.We could not confirm if there was a relationship established between the reported event and the device.The case screenshots were evaluated.A discussion with the reporter described what was done during the case and the screenshots were discussed in regard to their reflection of the description of the case conduct.A sawbones case was conducted to mimic the approach described of tracing the implant trial and collecting points inside that perimeter.The sawbones demonstration confirmed that because bone shown was an estimated surface rather than specifically mapped, it gave the appearance that the pointer probe was not in the proper location when touching the actual bone and expecting the pointer probe to be in that location on the bone model.This investigation concludes that the user falsely assumed that the system was showing actual location of some aspects of the model when those aspects were not specifically modeled due to a shortcut approach, the user attempted hoping to avoid what seemed to be "extra effort".The root cause of the event was insufficient operator training.

• 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: 9994088
• MDR Text Key: 189914734
• Report Number: 3010266064-2020-00250
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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?: Yes
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1