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 06/11/2019

Event Type  malfunction  

Event Description

It was reported that during a tka, pin placement, registration, implant placement had all progressed as per surgical technique. Immediately on distal femur burring a warning came up on the monitor - handpiece exposure control motor failure. Re-calibration of handpiece was undertaken and each time at the beginning of burring the same warning would be seen on the monitor. Handpiece and drill were inspected and connection of the two was re-confirmed without any problems found. A new handpiece and drill was opened and calibrated and procedure was completed without any further delay.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA ; 7634524980
• MDR Report Key: 9999463
• MDR Text Key: 189162583
• Report Number: 3010266064-2020-01451
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/26/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/29/2020
• 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