MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSD01008

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 12/23/2016

Event Type  malfunction  

Event Description

It was reported that the tissue protector got stuck on the distal femoral pin. Tried several methods to remove the tissue protector, but nothing worked. Tried cutting the top of the pin off, but this did not help. Ended up cutting through the tissue protector and the pin and then chucking the remaining portion of the tissue protector into a drill to remove the parts. Once removed, could see that the bottom of the pin was bent. The surgeon thought the pin might have bent when going into the posterior cortex and it might have gone through at an angle. Delay of 20 minutes and parts were cut to remove them.

• Brand Name: NAVIO BONE PIN 4.0MM X 127MM
• 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: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 4126833844
• MDR Report Key: 9747215
• MDR Text Key: 188487864
• Report Number: 3010266064-2020-00070
• Device Sequence Number: 1
• Product Code: OLO
• 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,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PFSD01008
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/23/2016
• 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