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

Model Number PFSR110137

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

Event Type  Injury  

Event Description

It was reported that when i went into the initial bur phase for the tibia, error that said something along the lines of ¿internal drill cabling error¿ occurred and it was forced to shutdown.Upon rebooting the unit, got another error: ¿an error occurred during initialization.Pfs control hardware failure.(errcode = 40000000000).¿ doctor continued as a manual procedure and after discussing, it was concluded that most likely, the handpiece malfunction and blew a fuse, so the siu is dead and needs to be replaced.

Manufacturer Narrative

The navio handpiece, used in treatment, was returned for further evaluation and a visual and functional evaluation was performed, which did not confirm the reported event.Nothing was identified visually that contributed to the reported problem.The cable insulation is torn below the handpiece side strain relief exposing internal conductors.Functional evaluation was performed, which did not confirm the reported problem.The handpiece test passed with a torque value of 18.During testing, the strain relief was flexed back and forth to try and duplicate the error.We pulled back the strain relief and the insulation about 1", as well as removed the collet holding the cable in the handpiece.Upon further review under a microscope, both shielding planes were broken however; the colored wires remained intact.The handpiece passed testing during functional evaluation.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during the release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio surgical system user¿s manual (500196 rev.C) was reviewed and it provides instructions on outlined in the ¿common problems & solutions table¿ section for all common issues before proceeding with manual instrumentation.Additionally, product labeling has been ruled out as an issue for this complaint.This failure is captured in the navio risk profile.Clinical/medical investigation noted that the surgery was completed as a manual procedure with a delay of fewer than 30 minutes.No clinical/medical documentation has been provided for this investigation.The impact to the patient beyond the minimal delay is likely none.The root cause was found to be no problem found.No corrective actions have been initiated for this issue.

• 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: 9999603
• MDR Text Key: 189086573
• Report Number: 3010266064-2020-01490
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2020
• 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?: Yes
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 220025, SIU, E00222.
• Patient Outcome(s): Required Intervention