MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO CHECKPOINT VERIFICATION PINS; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO

Catalog Number 101198

Device Problems Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 01/20/2018

Event Type  Injury  

Manufacturer Narrative

The investigation determined that the system warned the surgeon to remove the checkpoint pin during use.The on-site representative additionally reminded the surgeon to remove the checkpoint pin.It was further reported that the second surgery to remove the checkpoint pin (on the following day) resulted in successful removal without complication.This event was not caused by the navio system, instruments, nor the labeling of the equipment.

Event Description

It was reported an x-ray performed on (b)(6) 2018 confirmed that a check point pin had been inadvertently left in the patient during surgery the previous day.Revision surgery was performed to remove the pin.No injury or further complications were reported.

Manufacturer Narrative

H10: b4, g4, h2, h3, h6: updated information.H11: a1, b2, b5, d1, d4, g3, g5: corrected information.

Event Description

It was reported that, one day after a navio-assisted pfa surgery had been performed, the x-rays showed that a checkpoint pin was left in the patient.The surgeon performed a second surgery the next day to remove the pin.The patient outcome is unknown.

Manufacturer Narrative

H10: the device, used in treatment, was not returned for a prior investigation but was visually and functionally inspected by a company representative.During the evaluation, the onsite representative saw the system warn the surgeon to remove the checkpoint pin.The representative had to remind the surgeon to remove the checkpoint pin.Device history record review found that the reported product met manufacturing specifications prior to being released for distribution.A complaint history review found 3 reports of this issue and will continue to be monitored.The surgical technique guide released at the time of the complaint (pn 500097 revb) provides instructions for checkpoint pins.Specifically, the guide has a warming statement that states "prior to closing the patient's incision, be sure to remove both the femur and tibia checkpoint pins".It also states under installation of the checkpoint verification pin the following: "if, at any point during implantation, you revert to traditional implant methods, all checkpoint." per review of the instructions for use, there is sufficient information provided to alert the user about this type of issue.The user likely did not follow the instructions for use.This reported event is an identified hazard within the risk file.We are able to confirm there was a relationship established between the reported event and the device as the event was likely due to user error by the surgeon.Factors that may have caused the reported event was that the surgeon may have disregarded the alert on the device.No containment or corrective actions recommended at this time.Per complaint details, this was a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided the impact beyond the reported subsequent surgery to remove the pins could not be determined.No further medical assessment is warranted at this time.

• Brand Name: NAVIO CHECKPOINT VERIFICATION PINS
• Type of Device: STEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW; 2905 northwest blvd.; suite 40; plymouth MN 55441
• MDR Report Key: 7315495
• MDR Text Key: 101564871
• Report Number: 3010266064-2018-00002
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 101198
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR