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

Catalog Number NPFS02000

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2020

Event Type  Injury  

Event Description

It was reported that during a tka procedure, after completing the distal femur cut accurately, they placed the 5-in-1 cutting block on the femur and checked the anterior slot with the plane checker.It was 4 mm anteriorized to the plan on the screen.The surgeon posteriorized the block 2 mm (which required two additional bone holes to be made) and then rechecked the anterior slot, which read 0.9 mm anteriorized to the plan.Proceeded with the saw cuts and was satisfied with the final result.To troubleshoot, we checked the checkpoints and they passed, the handpiece array was verified secured, and when navigated the probe to the pilot holes, they were within the bounds.There was a delay of less than 30 minutes.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio surgical system us, part number npfs02000, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.Review of the patient screenshots confirmed the customer allegation of discrepancy between virtual bone model and actual cuts.A review of manufacturing 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 probable cause of the reported problem is potentially loose handpiece array or improper placement of the tracker arrays.The navio surgical technique manual (500197) provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿ section of ¿performing trial reduction and postoperative assessments.There is also guidance to attaching and positioning tracker arrays to the implant region as well as to the handpiece, which ensures correct location of implant region, handpiece and burr.Per the clinical evaluation, the complaint details revealed that the system malfunctioned during cutting plan.Based on the information provided, there was a delay of less than 30 minutes.No other complications were reported.There was no patient injury/impact and the procedure was completed with the same device.This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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.

• 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: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 4126833844
• MDR Report Key: 10228423
• MDR Text Key: 197542719
• Report Number: 3010266064-2020-01629
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other