MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM BE/FR/DE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71420574
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Inadequate Osseointegration (2646)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a navio-assisted pfa had been performed on the right side, the patient experienced synovitis and pain.The adverse event was treated with arthroscopic synovectomy; in such surgery, the patella was found to be damaged and probably caused synovitis to the unstable patellofemoral component.The patient is able to mobilise post-operatively.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the navio surgical system (be/fr/de), product npfs02020, used in treatment was not made available to the designated complaint unit for evaluation thus, visual inspection and functional testing could not be performed and a relationship between the reported event and the device was not confirmed.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, contributing factors may be component mismatch or unintended cut or damage to bone or tissue.The navio surgical technique guide (500197) provides instructions on consulting with implant manufacturer regarding implant compatibility and addresses methods to mitigate potential harm to bone and soft tissue.This failure is an identified failure mode within the risk assessment.Per complaint details from belgium, it was reported that after a navio-assisted pfa had been performed on the right side, the patient experienced synovitis and pain.The adverse event was treated with arthroscopic synovectomy; in such surgery, the patella was found to be damaged and probably caused synovitis to the unstable patellofemoral component.The patient is able to mobilize post-operatively.No additional patient injury or impact was reported and there were no further interventions necessary due to the reported event.Smith & nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received the complaint can be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO SURGICAL SYSTEM BE/FR/DE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10431956
• Report Number: 3010266064-2020-01722
• Device Sequence Number: 2344049
• Product Code: OLO
• UDI-Device Identifier: 03596010208293
• UDI-Public: 03596010208293
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420574
• Device Catalogue Number: NPFS02020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR