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

Model Number NPFS02000

Device Problem Image Orientation Incorrect (1305)

Patient Problem Injury (2348)

Event Date 08/29/2019

Event Type  Injury  

Event Description

It was reported that when checking tibia cut block with visualizer tool, numbers were off and tibia checkpoint had moved 6mm.Surgeon used back of clamps for checkpoint reference.Case was completed as a manual procedure.

Manufacturer Narrative

The device was being used during treatment when it was noted that the tibia checkpoint had moved.The log files nor any case screenshots were returned for evaluation.The dhr was reviewed for software version (rc-7007) and it has been validated.A complaint history review was performed and found 138 reports of the issue.This issue will continue to be monitored.The failure has been identified in the risk file.The surgical technique guide released at the time of the complaint (pn 500095 rev#d) provides instructions on how to attach bone tracking hardware (p.9).There is no indication in this complaint that the user did not follow the ifu.A relationship between the device and reported event has not been established.Without the actual log files or case screenshots, the issue could not be confirmed.A factor that could have contributed to the reported event was if the tracker was tightened on an edge instead of a flat.If tightened on an edge, the tracker can easily rotate to a flat during the case.The root cause of the reported event could not be determined.No corrective action or containment is recommended at this time.If the log files or case screenshots are returned, the complaint will be re-investigated at that time.Based on the information provided, the root cause could not be definitively concluded and further patient impact is not anticipated.No further medical assessment is warranted at this time.

• 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
• MDR Report Key: 9999316
• MDR Text Key: 189172906
• Report Number: 3010266064-2020-01405
• 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
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2020
• 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
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1