MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO

Model Number NPFS02000

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Joint Swelling (2356); No Code Available (3191)

Event Date 10/20/2017

Event Type  Injury  

Event Description

It was reported that the patient experienced hamstring irritation and ischial tuberosity bursitis that resulted in revision surgery to a total knee arthroplasty.

Manufacturer Narrative

Investigation narrative: the surgical questionnaire on the adverse event form noted that the issue was "possibly" related to the navio or the implant but also noted that it was "possibly" unrelated to the study.The navio¿ surgical system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, and assists in preparation of bone cuts, based on prosthesis plan, taking into consideration 3d bone anatomy and ligament structures.Evaluation of the system archive and screenshots of the patient's procedure indicates that the planned locations of the implant, the predicted gap/ligament balancing and leg alignment are consistent with the post op results.Therefore the navio system performed as expected (i.E.The planned outcome aligns with the achieved outcome).Furthermore, the patient's relevant medical history shows a previous left hamstring tear which is the same hamstring that was irritated and ultimately caused the decision to perform a tka revision.

Manufacturer Narrative

H10: a1, b5, b7, d6, d7, g3, g4, h6: additional information.

Event Description

[clinical study: 16-npfs-11; subject id: 30-013 baw; ae: 1] it was reported that, after a navio-assisted ukr surgery had been performed, the patient started experiencing hamstring irritation and ischial tuberosity bursitis.Although the patient initially was treated with medication and physical therapy, the event was resolved with a revision surgery.The patient is recovered.

Manufacturer Narrative

H10, h3, h6: the device was used in treatment and during a clinical retrospective study, the patient presented with hamstring irritation and ischial tuberosity bursitis, resulting in a revision to tka.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 1 (one) prior similar event, this issue will continue to be monitored.The risk assessment (pn 450006 x) 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 documentation from the study was returned and reviewed for investigation.The surgical questionnaire on the adverse event form noted that the issue was "possibly" related to the navio or the implant but also noted that it was "possibly" unrelated to the study.Evaluation of the system archive and screenshots of the patient's procedure indicates that the planned locations of the implant, the predicted gap/ligament balancing and leg alignment are consistent with the post op results.Therefore, the navio system performed as expected (i.E.The planned outcome aligns with the achieved outcome).Furthermore, the patient's relevant medical history shows a previous left hamstring tear which is the same hamstring that was irritated and ultimately caused the decision to perform a tka revision.The investigation concluded there was no fault in the product, and the device performed within expected parameters.

• Brand Name: NAVIO
• Type of Device: STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW; 2905 northwest blvd.; suite 40; plymouth MN 55441
• MDR Report Key: 7080653
• MDR Text Key: 93652764
• Report Number: 3010266064-2017-00018
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K160537
• 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: 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: Physician
• Device Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 11/05/2017; 04/23/2020; 08/17/2020
• Supplement Dates FDA Received: 06/13/2018; 04/24/2020; 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 110