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

Catalog Number NPFS02000

Device Problems Computer Software Problem (1112); Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  Injury  

Event Description

It was reported that during a procedure, during neutral collection on a lateral uka, surgeon received the message: "the kinematic axis was collected incorrectly and may be inaccurate".This error message occurred twice after recollecting ankle and hip centers, which led the surgeon to proceed anyway.Surgeon used a combination of manual and navio technique to finish the case.There was no delay or patient injury reported.

Manufacturer Narrative

H10 h3, h6: the device was used in treatment and case log files and screenshots were not returned for evaluation.Thus, visual inspection could not be performed.Dhr review found that the software version (rc-6001) has been validated.A complaint history review found 1 similar reports, this issue will continue to be monitored.This failure mode is identified within the risk assessment.The surgical technique guide released at the time of the complaint provides instructions for femur kinematic axis.The navio software requirements specification (800035), the kinematic axis consistency check requirement is that during the pre-operative kinematics stage, navio intra-op shall compare the kinematic axis of rotation with the initial long axis of the patient's leg (hip center to ankle center).For ukr, the kinematic axis shall be within 10 degrees of normal to the long axis.Therefore, it is possible that the patient's anatomy made it more than 10 degrees, which then caused the error multiple times.For example, if the joint was looser than normal, there could have been a lot of twisting while collecting the points, making it difficult for the system to identify the axis.However, since no log files or case screenshots were returned.We cannot confirm this.The root cause cannot be determined after investigation.A relationship between the device and the reported event could not be established.

• 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: 9993871
• MDR Text Key: 188846026
• Report Number: 3010266064-2020-00880
• 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: 08/27/2020

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention