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

Model Number NPFS02000

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

It was reported that, during navio tka procedure (while patient under anesthesia), upon handpiece registration the bur did not home.The surgeon did a handpiece test and it passed so he returned to the same case, but he had started and this time the registration was completed without issues.During the case, once they got to neutral leg collection, they got an error message saying the malleoli were collected incorrectly.The malleoli error message was after hip center.The surgeon hit the continue button to recollect the information once again and the same thing happened while trying to collect neutral leg alignment.At this point the surgeon ended the case and started a new one.The case was completed after a delay non greater than 30 min.Patient was not harmed.

Manufacturer Narrative

The product, navio surgical system (us), npfs02000, sn(b)(6) used for treatment was not returned for evaluation, however log files were provided for review.Screenshots during the case show the "collection error-the malleoli points were collected in the wrong order".A relationship between the reported event and the device was confirmed.A functional evaluation could not be performed because the device was not returned.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event may be associated with the incorrect collection of the malleoli points and/or the femoral tracker pointing toward the ceiling during neutral position collection.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 10701507
• MDR Text Key: 212075698
• Report Number: 3010266064-2020-01893
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• 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: 10/22/2021

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 Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1