MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number NPFS02000

Device Problems Display or Visual Feedback Problem (1184); Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 08/26/2019

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, the anspach drill did not spin when attempting to cut the femur: it moved in and out of the hand piece but did not spin.An error popped up on the anspach console screen.The drill was unplugged and re calibrated, but this did not solve the issue.Then a second navio tray was opened and replaced the drill.Again, the drill did not spin.The error was flashing even before the drill was activated with the foot pedal.The hand piece was not swapped.The surgery was resumed, after a surgical delay of 15-20 minutes, by using manual instruments.The patient outcome is unknown.

Manufacturer Narrative

The reported device, used for treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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 31 prior similar events.This failure mode will be trended to assess for any necessary corrective actions.The navio user¿s manual for (tka) user¿s manual (pn 500093 rev e) released at the time of the complaint provides detailed instructions for use of the anspach surgical drill console and foot pedal.The user¿s manual states: warnings: always operate the anspach emax 2 plus surgical bur with adequate irrigation.Failure to do so may result in damage to the bone surface, bone necrosis, or damage to the surgical bur or drill motor.The anspach emax2 plus surgical drill console is equipped with a peristaltic pump for irrigation.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 patient injury/impact to the patient; therefore, no further medical assessment is warranted at this time.Factors that could have contributed to the reported event may be due to a detected failure within the anspach console which is reported as e2.The e2 error is inferred by the console from the motor current applied and the resulting lack of motion when the collar is locked.The e2 error is cleared by releasing the lock and actuating the foot control.If this does not clear the error, it can be cleared by rebooting the system.

• Brand Name: NAVIO SURGICAL SYSTEM US
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN
• MDR Report Key: 9999314
• MDR Text Key: 189168564
• Report Number: 3010266064-2020-01407
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• 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: 08/13/2020

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 Model Number: NPFS02000
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 04/25/2020
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1