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

Catalog Number NPFS02000

Device Problem Image Orientation Incorrect (1305)

Patient Problem Injury (2348)

Event Date 04/16/2019

Event Type  Injury  

Event Description

It was reported that during tka case, rotation of 5-1 block was off 8-10 degrees, dark red painted of femur after switching back to bur screen and femur checkpoint off exactly again, 20mm.All cuts were verified with manual instruments and all accurate despite again the misalignment stated by visual guard.

Manufacturer Narrative

The device was being used during treatment when a checkpoint verification failed.The log files and case screenshots were returned for evaluation.The dhr was reviewed for software version (rc-6103) and it has been validated.A complaint history review found similar complaints of the reported issues and will continue to be monitored.The surgical technique guide released at the time of the complaint includes information for if the bone tracker array has moved during surgery.The relationship of the device and the reported event has been established.Review of the case screenshots found that the after cutting the femur, the femur checkpoint failed and moved by 21.8mm in checkpoint verification.There were no issues with the tibia checkpoint.The distance of 21.8mm could indicate that the tracker rotated from an edge to a flat.The user likely thought that the tracker did not move because everything could have looked fine visually and it depends when the tracker moved.The tracker could have rotated from the edge to the flat from the vibrations from burring the femur or the tracker could have been bumped slightly after the user finished cutting and switched to using the plate probe for visualize cut.While the tracker may seem tight and rigid even if it is tightened on an edge, it can still move to a flat during the case.The case screenshots show that the surgeon redefined the femur checkpoint, which does not realign the setup with the previous cut plan and should not be done unless it can be confirmed that neither tracker has moved.If the tracker has moved, redefining the checkpoints is not the solution.If the checkpoints are reset for the femur, the user needs to go through registration with the femur again (free collection, implant planning, refining, etc).Therefore, the root cause of the reported event was due to user error.Per complaint details, the device malfunctioned during use; the rotation of 5-1 block was off 8-10 degrees, dark red painted of femur after switching back to bur screen and femur checkpoint off exactly 20mm.All cuts were verified with manual instruments and all accurate despite the misalignment stated by visual guard.Based on the information provided, there was no patient injury/impact as the procedure was completed with the same device.

• 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: 9994243
• MDR Text Key: 188809549
• Report Number: 3010266064-2020-01093
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention