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

Catalog Number PFS02000

Device Problem Calibration Problem (2890)

Patient Problem Injury (2348)

Event Date 01/14/2019

Event Type  Injury  

Event Description

It was reported that in tka case, when attempting to place the 5 in 1 block using journey ii bcs, the surgeon placed the plane checker in the anterior plane and noticed that the angulation was off by 3.5 degrees and it was 1.4 mm proud.Dialed down the block a mm, pinned it, made the cut and the knee subsequently was a little tight in extension.Compensated for the tightness performing releases.

Manufacturer Narrative

H10 h3, h6: the device was used in treatment.Dhr review found that the software version has been validated.A complaint history review identified prior similar events, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The surgical technique guide released at the time of the complaint provides instructions for the user in the "recovery procedure guidelines" section.We could confirm there was a relationship established between the reported event and the device.The log files and case screenshots were evaluated.Review of the returned case screenshots found that screenshots were not manually taken during the plane visualization screens.Therefore, we cannot confirm that the plane was off as reported.The screenshots showed that when cutting the femur, the holes for the cut block were not completely drilled and still showed green portions to cut.Therefore, when the cut block was inserted, it could not be fully inserted into the holes and therefore could have caused a discrepancy.It is recommended for the user to switch to the 2mm bur in order to fully drill the hole, however the case screenshots show that the 5mm cylindrical bur was selected at the beginning of the case and was not changed.If the post holes are not completely drilled out and the 2 holes for the cut guide are not prepared as recommended, that could lead to the cut guide not being flat against the bone surface and it would not be in the right position.Some other possible sources for the discrepancy could be that the handpiece tracker was not completely tightened and moved or that the incorrect cut guide size was used.This was a preventable issue.The malfunction was due to a 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: 9998270
• MDR Text Key: 189409993
• Report Number: 3010266064-2020-01073
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFS02000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention