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

Catalog Number NPFS02000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Fibrosis (3167)

Event Date 04/03/2018

Event Type  Injury  

Event Description

It was reported the patient presented right knee arthrofibrosis after surgery and manipulation under anesthesia was done.

Manufacturer Narrative

H10: h3, h6: the device was used in treatment and during a clinical retrospective study, the patient presented with "right knee arthrofibrosis" at their 4 week post-op follow up.The software version was not recorded, but dhr review shows that all navio software versions released to the field have been validated.A complaint history review identified prior similar events, this issue will continue to be monitored.The risk assessment released at the time of the complaint was reviewed and it notes the intended use, indication for use, and design assumptions of the navio system.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.We could not confirm if there was a relationship established between the reported event and the device.This is part of a clinical retrospective study.The returned patient files were reviewed and showed that surgeon check that severity as "moderate", "not serious" and the event expectation was "anticipated." it was also marked as "ongoing" and actions taken to be "physical therapy, medication therapy, and surgery/procedure." it was likely that the arthrofibrosis could have been cause by lack of physical therapy.Discussion with medical affairs confirmed that arthrofibrosis can be typically tied to lack of physical therapy and we will continue to monitor this issue as the patient is enrolled in a clinical study.The investigation concluded there was no fault in the product, therefore it performed within the expected parameters.

• 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: 9993875
• MDR Text Key: 188826878
• Report Number: 3010266064-2020-00884
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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 Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR