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 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device used for treatment was returned for evaluation. The reported problem was visually confirmed, the snaplock nut is broken. Although the reported problem was visually confirmed, a functional evaluation could not be performed due to the broken snap lock nut. 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 the mechanical failure of the snap lock. As a part of corrective actions, a more robust design of the snap lock has been released.

Event Description

It was reported that the handpiece failed the first admin test with a 42 torque. The second admin test passed with a 20. No delay involved and it is unknown how the case was completed. No injuries 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: 10818923
• MDR Text Key: 215932360
• Report Number: 3010266064-2020-01984
• 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: 11/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PFSR110137
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse