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

Model Number PFSR110137

Device Problem Electrical Overstress (2924)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device used for treatment was returned for evaluation.The reported problem was not visually confirmed, however, the issue was confirmed when reviewing the case screenshots and log files.A review of the returned log files found multiple ¿over current¿ errors associated with ¿errordb-cutfemur¿ and ¿errordb-homehandpiece.¿ these ¿over current¿ errors in the log files were presented as ¿handpiece exposure motor control failure¿ and ¿handpiece error¿ (for homing) messages on the navio system.This is indicative of a connection/wiring issue within the handpiece.During the functional evaluation of the handpiece, a case was attempted and the handpiece incurred a homing error.This also confirms there is a connection/wiring issue within the handpiece.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 associated with the navio handpiece and failure mode(s) "error message(s)" identified similar events.The most likely cause of this event is an electrical failure of the handpiece cable.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during a tka procedure, a ¿hand piece exposure control motor failure¿ error appeared while burring on the distal femur.It was hit dismiss and re-calibrated, but the same error was received again.The handpiece was switched out, re-calibrated and the case was able to be resumed with a delay of fewer than 30 minutes.No other complications were reported.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 38116 ; 4126833844
• MDR Report Key: 10864398
• MDR Text Key: 217071077
• Report Number: 3010266064-2020-02012
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1