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

Catalog Number ROB00049

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

Patient Problems Injury (2348); Deformity/ Disfigurement (2360)

Event Date 09/29/2020

Event Type  Injury  

Event Description

It was reported that, after a navio procedure, the tibia was noticed in excessive varus and femur in valgus.It seems like there has been a mal-positioning of the components potentially due to incorrect malleolus collection.No other complications have been reported.It is unknown if a revision surgery will be performed in the future to correct the problem.

Manufacturer Narrative

Additional information: h4.H3, h6: the navio surgical system (uk), product rob00049, (b)(6) used for treatment was not returned for evaluation, however visual evaluation was possible through pre/post op x-rays, knee visualizer images and navio screenshots relevant to the case.A relationship between the reported event and the device was confirmed.The x-rays show mal-positioning of components: the tibia is in excessive varus and femur in valgus.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.Although the reported problem was confirmed visually, the root cause is undeterminable.A factor that may have contributed to the reported symptom may have been associated with incorrect malleolus collection.The navio surgical guide/technique notes should a failure occur, to abandon the navio for manual technique.This failure is an identified failure mode within the risk assessment.The medical investigation found that this complaint from the united kingdom reports that a post navio tka procedure resulted in a "tibia is in excessive varus and femur in valgus.It seems like there has been a mal-positioning of the components potentially due to incorrect malleolus collection.No other complications have been reported.¿ the provided x-ray appears to show mal-positioned tka components with tibial baseplate overhang and supports the complaint but cannot be confirmed based on the limited view.Per correspondence, it is likely that a revision will be required, as the surgeon is extremely unhappy with the result; although it was reported that the patient is ¿pain-free at the moment¿.The navio surgical guide/technique notes should a failure occur, to abandon the navio for manual technique.In conclusion: based on the information provided, the root cause of the reported event could not be definitively concluded; however, the potentially incorrect malleolus data collection cannot be ruled out as a contributing factor of the mal-positioned components.Additionally, as stated in the surgical technique the surgeon may opt to abandon the navio and proceed with a manual technique should a failure occur during any stage (including data point collection, bone removal, sizing/placement, etc.).The patient impact beyond the reported gross mal-positioned components could not be determined, as it was reported that the patient is currently pain free and although revision is reported as 'likely¿, it remains unknown if additional procedures have been scheduled/performed.No 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.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 at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO SURGICAL SYSTEM UK
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10701776
• MDR Text Key: 212064648
• Report Number: 3010266064-2020-01896
• 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: 09/22/2021

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: ROB00049
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability