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 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.Functional evaluation was performed.The motor gear in the handpiece could not be manually turned.The handpiece was sterilized prior to the handpiece characterization test because the heat can potentially bind the motor gear.The handpiece characterization test was conducted with a torque (t1) value of 58.The test was conducted twice more, with torque values of 30 and 20 respectively.This indicates early signs of motor failure.A review of manufacturing records indicate the device met all specifications upon release into distribution.A review of service records indicate the handpiece motor met specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the handpiece and failure mode(s) "jamming/seizing" 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 conducting to determine if additional actions are required.

Event Description

It was reported that before a ukr procedure, the gears were stuck on the handpiece.It would not even perform the troubleshooting test.No movement at all.There was a backup device available and no delays in the procedure.No patient injuries or 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: 10708344
• MDR Text Key: 212280928
• Report Number: 3010266064-2020-01901
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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: 10/18/2020
• 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