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

Catalog Number NPFS02000

Device Problem Failure to Calibrate (2440)

Patient Problem Injury (2348)

Event Date 11/09/2016

Event Type  Injury  

Event Description

It was reported that during ukr case the hip center calculation was attempted with difficulty several times.The initial error was 3.1mm and subsequent attempts resulted in errors ranging from 3.4 to 1.0.It was unable to proceed past the calculation page using the override or proceed functions as they were never present.Readjusted the camera stand location to eliminate any camera view error and asked the surgeon to calculate hip center again.Then exited the plan and re-entered the plan with no improved outcomes.Calculation was attempted a third time and again was unable to achieve an acceptable error or use the proceed or override options.Finally first assist attempted to stabilize the pelvis and hip joint which resulted in an error of 1.0mm with all of the segments of the grid appearing bright green.Still unable to proceed, so the case was completed with manual instrumentation.

Manufacturer Narrative

H10: the device was used during treatment when the system was unable to move beyond the hip center stage.Review of the screenshots and log files indicate that the third attempt was not fully completed and had not yet turned green.This is the reason the accept button was not present.Dhr review found that the software version (navio rc-4104) had been validated.A complaint history review found a complaint of the reported issue and it will continue to be monitored.This failure has been identified in the risk file.The surgical technique guide released at the time of the complaint provides instructions for hip center calculation.The relationship of the device and the reported event has been established.Review of the log files confirmed the system acted appropriately for the hip center stage.In order to advance beyond hip center without receiving a "passing" error, you must attempt 3 hip center collections and the last must be completed.The log files indicate that the 3rd hip center that was attempted was never a completed and there was one unfilled section each time.Each time the hip center stage is re-entered, the count resets itself.There was no evidence of incorrect software computation or bug as the system and software behaved as expected.There was no problem found.Per complaint details, the device system malfunctioned during use; after trouble shooting, we were still unable to proceed in the case.Based on the information provided, there was no patient injury/impact as the procedure was completed with manual instrumentation.No further medical assessment is warranted at this time.

• 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: 9989184
• MDR Text Key: 189345726
• Report Number: 3010266064-2020-00344
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• 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