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

Model Number PFSR110137

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device intended for use for treatment was returned for evaluation.Nothing was identified visually that contributed to the problem.A functional evaluation was completed and the reported problem was confirmed.The handpiece test failed because the handpiece would not home.The drill guide is bent, which is causing excessive strain on the snaplock nut/worm screw assembly.This then creates a connection error when these gears lock up.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) "jamming/seizing" identified similar events.The most likely cause of this event is improper handling of the handpiece.Care and caution should be exercised during the surgical site set up and tear down to protect the handpiece from an unforeseen force, such as falling on the ground or damage during transport.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.No further containment or corrective actions are recommended at this time.

Event Description

It was reported that before surgery, the handpiece would not calibrate.The handpiece was swapped for a backup available to continue with the procedure without delays.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: 10708809
• MDR Text Key: 212319711
• Report Number: 3010266064-2020-01905
• 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: 10/19/2020
• 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