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

Catalog Number NPFS02000

Device Problems Mechanics Altered (2984); Unintended Application Program Shut Down (4032)

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

Event Date 01/27/2020

Event Type  malfunction  

Event Description

It was reported that after finishing distal femur burring for tka demo, they were prompted to recalibrate the handpiece before moving on to the tibia burring.They were able to recalibrate and finish burring the tibia, but after all the cuts were made, the doctor wanted to make an adjustment to the plan, so they went back to the planning screen.After making the changes, they were unable to move into the cutting screens because the button on the screen wouldn¿t light up.Tried switching to bur all but that didn¿t help.Tried going back and undoing the changes but nothing allowed to move forward.Quit the case, logged out, reopened and surgery was completed (the ¿cut femur¿ button could not be selected unless they quit the case and reopened).No patient involved.The investigation found that there were multiple pfs errors and an exposure motor control 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 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: 12116318
• MDR Text Key: 260540694
• Report Number: 3010266064-2021-00511
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1