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

Model Number PFSR110137

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and the reported problem was confirmed.The handpiece would not home after calibration.When performing the handpiece characterization test, which helps determine appropriate motor function, the torque value was 72, which exceeds the maximum acceptable value of 40.The handpiece was then sterilized and the handpiece characterization test was performed again, where the torque value was 56.The handpiece characterization test was completed for a third time, where the torque value was 76.This is indicative of the handpiece motor failure.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 handpiece and failure mode(s) "homing failure" identified similar events.The most likely cause of this event is the mechanical failure of the motor.Further investigation into the reported failure is being conducted to determine if additional actions are required.

Event Description

It was reported that before the procedure, navio handpiece failed to home after calibration multiple times.It was swapped out for its backup to continue the case and no patient impact was 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: 10803984
• MDR Text Key: 215279022
• Report Number: 3010266064-2020-01962
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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
• Date Manufacturer Received: 11/02/2020
• 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