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

Catalog Number PFSR110137

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device used for treatment was returned for evaluation. Nothing was identified visually that contributed to the reported problem. A functional evaluation was attempted and the reported problem was confirmed. The handpiece was sterilized, then the handpiece characterization test was performed twice, where both t1 torque values were 98. The motor could not be manually turned. These torque values indicate the motor is not functioning properly. 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 motor failure. When the handpiece homes, it wants to move the burr to the calibration wall. However, because of the motor failure, the handpiece could not extend and retract the burr which caused the homing failure. Further investigation into the reported failure is being conducted to determine if additional actions are required.

Event Description

It was reported that during handpiece registration the bur would not home. The handpiece was replaced and the case was performed without issue. The gears on the first handpiece were completely frozen/locked up. No delay 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: 10825586
• MDR Text Key: 215932958
• Report Number: 3010266064-2020-01990
• Device Sequence Number: 1
• Product Code: OLO
• 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

• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse