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

Catalog Number PFSR110137

Device Problem Electrical Shorting (2926)

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

Event Date 09/26/2018

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, the handpiece jammed and an error was displayed.The handpiece was opened and inspected and looked fine internally; then, when trying to rehome, it was displayed an internal cable error.The handpiece was swapped, but the same error appeared.When trying to reboot, there was a pfs error and did not boot.The surgery was converted to manual technique and was delayed, but the length is unknown.The patient outcome is also unknown.The result of investigation indicate that the damaged cord caused a short circuit that blew a fuse in the siu, which is a reportable malfunction.

Manufacturer Narrative

H10: the device was used during treatment and was returned, along with photos, for investigation.The initial functional evaluation of the handpiece found there was a short in the cabling.The dhr was reviewed and the product met manufacturing specifications.A complaint history review found similar complaints of the reported issues and will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable, etc.Since the reported event was related to a component failure, there is no indication in this complaint that the user did not follow the instructions for use.This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.The short in the handpiece cabling caused the blown fuse in the siu.The root cause of the reported event was due to an electrical component failure.Per complaint details, the device malfunctioned during use and the navio was abandoned for manual instrumentation.Based on the information provided the modified procedure and surgical delay did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time.Rosie payne rn special medical investigator.

Manufacturer Narrative

D11: corrected.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993972
• MDR Text Key: 189025091
• Report Number: 3010266064-2020-00724
• Device Sequence Number: 1
• Product Code: OLO
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIU - (B)(4).
• Patient Outcome(s): Required Intervention