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

Catalog Number NPFS02000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  Injury  

Event Description

It was reported that, during a navio tka procedure, when using the visualization disk they noticed the femur cut block seemed too anterior that they would not be cutting any bone. They thought they had sized the femur too large (size 7) so they went back and planned for a size 6. This still seemed anterior. They then checked checkpoints and the femur array was off by 5. 4 mm. They redefined the femur checkpoint and cut the tibia since that array hadn't moved. Then manually placed the 5-in-1 cut block for the femur. The surgeon insists that the femur array did not actually move and said it was locked on very tight and he could not physically move it (from what was witnessed, the surgeon pulled on the entire femur array multiple times to move the patients leg. While the array was secured tightly on the bone pins, he was cautioned that the pins may have become loose/moved in the femur). So, in summary, it was used navio for tibia and distal femur resection, then manual instrumentation to set femur cut block and check gaps. There was a delay of fewer than 30 minutes. The surgeon was pleased with the results; gaps were perfectly balanced. No other complications were reported.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11144542
• MDR Text Key: 226000357
• Report Number: 3010266064-2021-00027
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/10/2021 Patient Sequence Number: 1