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

Catalog Number NPFS02070

Device Problems Application Program Problem: Parameter Calculation Error (1449); Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 07/02/2019

Event Type  Injury  

Event Description

It was reported that surgeon uses the kinematic alignment method for knees.Both femur and tibia were planned and executed as usual, however patient had no fixed flexion and some varus wear pre-op.After the planned cuts, there was over 20 degrees of fixed flexion.The data from the software also suggested the patient was severely valgus, which wasn't the case.The surgeon ended up taking an additional 5mm of distal femur which still did not fully correct this.Surgery was extended more than 30 minutes.

Manufacturer Narrative

H10: a1, d10, h3: updated information.H11: b1, b2, b5.D4, g3, g4, h1, h6: corrected information.

Event Description

It was reported that, during a navio-assisted tka surgery, although the surgeon uses the kinematic alignment method for his knees, both femur and tibia were planned and executed as usual; however, the results were different from planning.The patient showed little varus wear and no fixed flexion pre-op; however, after the cuts she presented with over 20 degrees of fixed flexion.The data from the software also suggested that the patient was severely valgus, which was not the case.It had to be cut an additional 5mm distal femur to correct this problem.Surgery was extended more than 30 minutes.The patient outcome is unknown.

Manufacturer Narrative

The device was used in the treatment and case screenshots were returned.Dhr review found that the software version has been validated.A complaint history review found similar reports, this issue will continue to be monitored.This is an identified failure mode within the risk file.The surgical technique for tka (500095) provides instructions for implant planning and system usage.The case screenshots were reviewed and it was found that the full rom gap screen showed that 15 degrees of fixed flexion contracture was described.The overall alignment was 0 degrees, which is the expected alignment of the long leg axis.Since the values are taken from hip to ankle center, this aligns the leg to be straight, even if the gaps are tilted.The first plan by the user was tight medially and the gaps were around -5.4, full extension could not be achieved.Typically, the solution, in this case, would be to take more distal femur bone.The user cuts the tibia, lowered the tibia implant, cut, refined, and burred, which is also a correct way of achieving the desired result.It was reported that the surgeon took an additional 5mm of bone to correct that the patient was in valgus.The screenshots showed that the implant was adjusted by 5 clicks, which is 2.5mm more bone.After the adjustment, the final position of the implant was so that gaps were 0-1mm.This adjustment also resolved around 5 degrees of flexion contracture.The joint was balanced by changing the valgus of the femur.The screenshots show that an iterative planning method was used to tension the joint.It is imperative to consider the amount of distal resection so that there is not too much tightening of the joint.In this case, the navio system performed within expected parameters, but the surgeon's expectation of the system did not align with the actual capabilities of navio.No containment or corrective actions are recommended at this time.The clinical/medical investigation found that based solely on the engineering evaluation, surgeon expectations versus navio limitations contributed to the reported events.The patient impact was most likely limited to the 30-60 minute surgical extension during which the flexion contraction was improved by iterative cutting with no patient injury reported beyond the >30 min extension and some possible residual valgus per the report.No further medical assessment can be rendered at this time.

• 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: 8824459
• MDR Text Key: 152160843
• Report Number: 3010266064-2019-00105
• 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,Followup
• Report Date: 08/28/2020

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: NPFS02070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 04/23/2020; 08/28/2020
• Supplement Dates FDA Received: 04/26/2020; 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention