MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2020

Event Type  Injury  

Event Description

It was reported that during a navio procedure, there was an pfs control failure during case.The handpiece was replaced and the system was rebooted, but an error occurred during initialization: pfs control hardware failure.(errcode = 400000000000).The procedure was continued with manual instruments.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio handpiece, part number pfsr110137, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The evaluation followed a performance verification.The device performed as intended with no errors present during evaluation.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is potential 4-10 error induced by a handpiece used prior to the one associated with this case.The surgical technique guide provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿ per the clinical evaluation, there was no reported patient injury/impact resulted.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10521233
• MDR Text Key: 206513279
• Report Number: 3010266064-2020-01758
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention