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

Catalog Number PFSD01008

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 07/06/2016

Event Type  Injury  

Event Description

It was reported that when the surgeon was drilling the bone pin into the tibia, the back of the pins sheared off (the part of the pin which connects to the bone pin driver).This was the second pin going into the tibia, and he was driving it through the tissue protector.As he drilled, the drill struggled to spin and the torque was causing his drill and hand to spin versus the pin.The pin was left in to proceed with the case as there was enough room to attach the tracker.When it came time to remove the pin, a jacobs chuck was directly connected to the pin and was able to reverse.No delay or patient injury reported.

Manufacturer Narrative

H10 h3, h6: the device, used for treatment, was returned for evaluation.Visual inspection of the returned bone pin revealed that the break appeared to be only torsional in nature, with no signs of bending prior to the torsional break.The bone screw head broke at approximately 44 in-lbs.The pattern of the break was consistent with the returned material.The screw was most likely binding on another material (other than bone) like tissue or possibly the tissue protector.A review of the device history records (dhr) showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review identified similar events.This failure mode is identified within the risk assessment.The navio system for unicondylar knee replacement (ukr) user's manual (pn 500054 rev g) released at the time of the complaint provides detailed instructions for placing the bone pins and tracker arrays.The user is instructed to instructed to keep the drill in line with the pin when attaching/detaching.The user's manual also states that the navio instrument kit consists of a two-level tray that contains the required instrumentation for the navio¿ system provides a full traditional surgical instrumentation tray for the chosen implant should be available during every system use to manually implant the prosthesis in the event of system failure.It is recommended that users have fully populated and sterilized backup trays on-site at the time of the operation in the event that any parts malfunction or become damaged during the procedure.We were able to confirm there was a relationship established between the reported event and the device.The malfunction is likely due to deformation of the bone pin consistent with a torsional failure.The root cause is mechanical component failure.The triangular cross-section of the screw which interfaces with the driver was too small to withstand the applied torque.

• Brand Name: NAVIO BONE PIN 4.0MM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9989215
• MDR Text Key: 188648543
• Report Number: 3010266064-2020-00271
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention