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

Model Number PFSR110164

Device Problems Material Separation (1562); Solder Joint Fracture (2324)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2019

Event Type  Injury  

Event Description

It was reported that the inside of the pin driver, that supports the pin, detached from the rest of the driver while inserting bone pins.Doctor used speed pin adapter from journey set to complete procedure.No delays and no patient injuries involved.

Manufacturer Narrative

The device was used for treatment.The 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 specifications 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.¿ per complaint details, 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 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 corrective action has been requested.

Manufacturer Narrative

H10: a1, d10, h3: updated information.H11: b1, b2, g5, h1, h6: corrected information.

• 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 55441
• MDR Report Key: 9258175
• MDR Text Key: 188489258
• Report Number: 3010266064-2019-00127
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110164
• 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