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

Catalog Number ORNPFS02070

Device Problem Failure to Calibrate (2440)

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

Event Date 07/15/2019

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, calibration passed but failed on the homing screen.It was tried several times to home the burr, but the drill was not advancing through the hand piece and consistently failed.A new burr was opened and installed correctly; recalibration process was completed, but failed to home again.The case was aborted and the surgery was finished with manual instrumentation.Surgery was not significantly delayed.The patient outcome is unknown.

Manufacturer Narrative

The device was used during treatment and was returned for evaluation.The dhr could not be reviewed and it was not confirmed if the product met manufacturing specifications.A complaint history review found 1 report of the issue and it will continue to be monitored.The surgical technique guide, released at the time of the complaint (b)(4), provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable., etc.Since the reported event was related to a component failure, there is no indication in this complaint that the user did not follow the ifu.The relationship of the device and the reported event could be established.The device was evaluated and found the epos module had failed, which caused the error code ff08 to appear and the device to fail homing.Therefore, the reported event was confirmed.The root cause of the reported event was software failure.

• Brand Name: NAVIO SURGICAL SYSTEM AU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999175
• MDR Text Key: 188937664
• Report Number: 3010266064-2020-01365
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ORNPFS02070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other