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

Catalog Number NPFS02000S

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

Patient Problem Injury (2348)

Event Date 09/28/2020

Event Type  Injury  

Event Description

It was reported that, during navio-assisted unknown procedure, while patient under anesthesia, the surgeon was not using the milling tool for the first cases, and decided to use for the first time this week in which he managed to over resect.The patient outcome is unknown.

Manufacturer Narrative

The navio surgical system us, pn: npfs02000, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The product was not returned however the software files were downloaded from the device and provided for investigation.The screenshots confirmed significant red of the femoral condyle.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.From the documentation provided, the clinical/medical evaluation concluded that the surgical technique could not be ruled out as a contributing factor to the reported eventsno further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.This case was put in casevisualizer, where it was confirmed that the checkpoints were on the bone, thus ruling out tracker movement.The screenshots show that the checkpoints passed.As reported, the user was moving the drill quickly and over differing resection planes.Over-resection is possible when the bur is exposed and the drill moves quicker than the expected retraction time.This is most noticeable when the guard is at an angle with, and not perpendicular to, the bone.When removing bone, the navio user¿s maual instructs the user to move the bur slowly and avoid touching anything other than the target bone.The surgical technique guide instructs the user to remove bulk bone with the following instructions: a slow, methodic ¿plunge and drag motion¿ through to the cortical layer, will remove bone with the greatest efficiency.The bur will stay protruded only until it has reached the target surface and the bur exposure will be actively adjusted so that cutting beyond the target surface is minimized.Widen the cut, moving at a deliberate pace.Trace around the outer edge of the implant cut plan.Make left-right or up-down passes to remove the remaining middle bone.Avoid quick passes, or ¿feathering¿, the tool over the surface.Methodical motion will remove bone with the greatest efficiency.Move from the anterior down to the distal part of the condyle.Continue to cut down to the posterior until you cannot access any more femur area.Increase flexion to maximize access while moving down the condyle.When burring bone near and around the collateral capsular structure (medial collateral ligament, mcl, or lateral collateral ligament, lcl) ensure that a retractor is used to prevent the bur from cutting the ligament.This situation was captured in the navio risk assessment released at the time of the complaint.It was determined that the software functioned as intended; no defect of the system occurred.Based on the investigation, no containment or corrective actions are recommended at this time.

• Brand Name: NAVIO SURGICAL SYSTEM SERVICE US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10701886
• MDR Text Key: 212047922
• Report Number: 3010266064-2020-01897
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628829
• UDI-Public: 885556628829
• 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: 09/16/2021

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: NPFS02000S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability