MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110164

Device Problems Break (1069); Mechanical Problem (1384); Solder Joint Fracture (2324)

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

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

The associated complaint device was returned and evaluated.Upon review of the returned pin driver, we were able to confirm the complaint.The inner cylinder of the pin driver had fallen out.This is consistent with bug 614, the product support engineering team has been made aware of this occurrence and is working to fix the issue.

Event Description

It was reported that the bone screw pin driver broke apart while on reverse in the process of removing a pin.The inside piece came loose and detached from the rest of the driver.Nothing fell into the wound, there was no negative affect on the case.And procedure was completed using the speed pin adapter from the journey instrumentation set.

Event Description

It was reported that the bone screw pin driver broke apart while on reverse in the process of removing a pin.The inside piece came loose and detached from the rest of the driver.The piece did not fall into the wound.The procedure was completed using the speed pin adapter from the journey instrumentation set.No surgical delay or patient injury reported.

Manufacturer Narrative

The device, was used for treatment.Visual inspection confirmed the issue and functional inspection confirmed that the inner cylinder of the pin driver would spin freely when spinning it around a bone screw.A review of the device history records 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 will be trended to assess for any necessary corrective actions.This failure is an identified failure mode within the risk file.The navio surgical technique guide (pn 500099 rev c) released at the time of the complaint provides instructions on the navio instrumentation kit.It states that ¿the navio instrument kit consists of a two-level tray that contains all of the required instrumentation for surgery using the navio surgical system.If the equipment breaks or fails during surgery, a sterile backup tray is on-site and can be unwrapped to replace a broken or dropped tool.¿ it also has a warning which states:¿ 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.¿ the device malfunction occurred during surgery.Based on the information provided, the procedure used the journey instrumentation set to complete the surgery.There was no reported delay, no patient injury/impact to the patient; therefore, no further medical assessment is warranted at this time.We were able to confirm there was a relationship established between the reported event and the device.The malfunction is due to a deficiency of the pin driver where the laser weld that attaches the outer tube to the inner cylinder with the triangular geometry fails, causing the outer tube to spin without spinning the screw.This issue is being further investigated and a corrective action has been requested.

• Brand Name: NAVIO BONE SCREW DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN
• MDR Report Key: 9504406
• MDR Text Key: 188506659
• Report Number: 3010266064-2019-00143
• 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,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR