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

Model Number NPFS02000

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348)

Event Date 11/20/2018

Event Type  Injury  

Event Description

It was reported that after a tka procedure patient exhibited decreased range of motion in left knee with instability.A revision surgery was performed to exchange polyethylene and tibial component.

Manufacturer Narrative

H10: a1, a4, b7, d10, h3: updated information.H11: b5, g3, g5, h5, h6, h8: corrected information.

Event Description

It was reported that, after a navio-assisted tka procedure had been performed, the patient exhibited decreased range of motion and instability.This event, related to the navio system, was resolved by performing a revision surgery.

Manufacturer Narrative

The device was used in the treatment and case log files and screenshots were not returned to the designated complaint unit for evaluation, thus visual inspection could not be performed.A complaint history review found similar reports, this issue will continue to be monitored.The software version was not recorded, but the dhr review shows that all navio software versions released to the field have been validated.This failure is an identified failure mode within the risk assessment.The surgical user's manual released at the time of the complaint (pn 500097 rev e) provides instructions for troubleshooting and usage of the device.A relationship, if any, between the subject device and the reported event could not be determined.There is not enough information to determine the factors that could have contributed to the reported issue.No containment or corrective actions are recommended at this time.If the case log files and screenshots associated with this event are returned at a future date, this evaluation will be reopened for investigation.The performed clinical/medical investigation indicates that no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Should any additional information be provided, this complaint would be re-assessed.

• 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: 9226226
• MDR Text Key: 163551510
• Report Number: 3010266064-2019-00120
• 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,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?: No
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 04/23/2020; 08/28/2020
• Supplement Dates FDA Received: 04/27/2020; 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 100