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 09/12/2018

Event Type  Injury  

Event Description

It was reported that patient had left knee arthrofibrosis after primary surgery and manipulation under anesthesia was performed to resolve the event.

Manufacturer Narrative

H10 h3, h6: the device was used in treatment.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 (pn 500095 rev c) 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.Patient files showed that the surgeon checked that the severity was "moderate" and "serious".The event expectation was "unanticipated" and the actions taken were "physical/physio therapy", "medication therapy", and "surgery/procedure".The outcome is "recovering/resolving" and it says that it was "possibly" related to navio.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: 9993874
• MDR Text Key: 188846088
• Report Number: 3010266064-2020-00888
• 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: 08/23/2020

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?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 94