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

Catalog Number NPFS02000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 05/23/2014

Event Type  Injury  

Event Description

It was reported that during case the graph was not representative of what the outcome was.Doctor discussed the placement of the implants in depth before moving past the gap balancing screen.Based on the looseness felt in the joint itself when planning the placement, essentially ignoring the gap graph.After placing the implants, as planned, determined there was about 1-3mm of looseness throughout the entire range of motion.It was reported that during surgery the plan did not match the outcome and more tibia had to be removed to finish the procedure.

Manufacturer Narrative

H10: the device was used in treatment and it was reported that the gap planning graph did not represent the outcome after burring.Case log files and screenshots were not returned for evaluation.Dhr review found that the software version (r-3101) has been validated.A complaint history review found similar reports, this issue will continue to be monitored.A relationship between the device and the reported event could not be established.The naviopfs system for unicondylar knee replacement (ukr) (500001 revi) provides instructions for using the system and how to use it for implant planning and collecting range of motion data.This issue is an identified risk in within the risk assessment.The root cause of the issue could not be determined.A potential factor that could have contributed to the reported issue is if the join was overstressed during range of motion data collection.Per complaint details, this represents a procedure complication and does not represent a device malfunction.Based on the information provided, there was no surgical delay or patient injury/impact as a result of the reported event.Therefore, no further medical assessment is warranted.

• Brand Name: NAVIO SURGICAL SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; ste 40; plymouth, mn
• MDR Report Key: 9999659
• MDR Text Key: 188988334
• Report Number: 3010266064-2020-00148
• 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
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1