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 Failure of Implant (1924); Nerve Damage (1979); Pain (1994)

Event Date 01/13/2020

Event Type  Injury  

Event Description

It was reported that, after undergoing a navio unicompartmental procedure in (b)(6) 2020, the patient experienced loose feeling and had pain in surgical leg.The nerve conduction studies showed loss of the great saphenous nerve and currently the patient continue to lose nerve function in the leg.

Manufacturer Narrative

H3, h6: the navio surgical system (us), product npfs02000, used for 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, a contributing factor may be unintended cut or damage to bone or tissue.The navio surgical technique guide (500197) provides instructions on mitigating potential harm to bone and soft tissue.The ifu [81087148 rev a] knee systems does note that peripheral neuropathies have been reported following total joint surgery.This failure is an identified failure mode within the risk assessment.The medical investigation found that this complaint from the united states reports that the patient underwent a navio uni knee arthroscopy in (b)(6) 2020 and continued to lose feeling and had pain in their surgical leg.Reportedly, nerve conduction studies showed loss of the great saphenous nerve and currently they continue to lose nerve function in the leg.No additional medical interventions were reported.Smith & nephew has not received adequate materials (operative reports: medical records, surgical site, surgeon, nerve conduction studies, imaging studies, including x-rays, fluoroscopy images, ct scans, bone scans and/or mri scans) to fully evaluate the root cause of the reported event, 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.G1.

• 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 55441
• MDR Report Key: 10621638
• MDR Text Key: 209636416
• Report Number: 3010266064-2020-01812
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other