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

Model Number NPFS02000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); Fibrosis (3167)

Event Date 11/05/2017

Event Type  Injury  

Manufacturer Narrative

Patient files showed that the surgeon checked that the severity was "severe" and "serious".The event expectation was "unanticipated" and the actions taken were "physical/physio 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.Medical affairs also noted that as arthrofibrosis is a known complication of the procedure, it would not be unanticipated.

Event Description

It was reported that after tka patient had arthrofibrosis in right knee requiring manipulation under anesthesia to treat the event.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

Clinical study.It was reported that patient had hamstring irritation and ischial tuberosity bursitis, this as a result of a total knee arthrosplasty.Report indicate that a revision surgery to tka was performed to alleviate patient hamstring pain.

Manufacturer Narrative

A follow up mdr was sent incorrectly via manual submission for this submission.Please disregard such follow up and for future references please refer to submission 003.

• 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 MN 55441
• MDR Report Key: 9677333
• MDR Text Key: 177999062
• Report Number: 3010266064-2020-00018
• 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,Followup,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 110