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

Catalog Number NPFS02000

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 04/29/2014

Event Type  Injury  

Event Description

It was reported that during case the gap planning graph did not represent the outcome after burring.After placing the trials, the surgeon determined that the joint was too tight, well under the 2mm represented by the graph.After determining that the joint was too tight, dropped the tibia 3mm.After burring more and putting the trials on, the surgeon determined there was about 2mm throughout the range of motion.

Manufacturer Narrative

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 at this time.

• 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: 9996800
• MDR Text Key: 188875550
• Report Number: 3010266064-2020-00146
• 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: 04/24/2020
• 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