MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number PFSR110164

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that while using navio drill to remove bone pins the inside of the drill fell out. Another drill was used to complete procedure and no delays or patient injuries were reported.

• Brand Name: NAVIO BONE SCREW DRIVER
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222
• MDR Report Key: 9448636
• MDR Text Key: 188489511
• Report Number: 3010266064-2019-00140
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PFSR110164
• Device Catalogue Number: PFSR110164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/01/2021
• 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