MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM BE/FR/DE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02020

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that during navio ukr procedure, the footswitch does not work.It is not actually the footpedal that has the issue, but the female housing on the navio.One of the little tubes that is in the housing has been pushed back and that¿s why the connection for the blue footpedal won't work.Surgery was delayed (unknown delay) and it was completed with manual procedure.No other complications were reported.

Manufacturer Narrative

The navio surgical system (be/fr/de), product npfs02020, (b)(6) used in treatment was not made available to the designated complaint unit for evaluation thus, visual inspection and functional testing could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.This failure mode is identified in the risk profile.The navio surgical technique guide (500197) provides instructions on how to revert to a manual case from a system failure and there is a label warning to have a sterile manual tray available.A relationship between the reported event and the device could not be established as the product was not returned.Although the reported problem was not confirmed, a contributing factor may be a cable/connector electrical component failure.Per complaint details from the netherlands, it was reported that during a navio ukr procedure, one of the tubes in the female housing had been pushed back resulting in a disconnect to the foot pedal.Based on follow up information provided, there was a surgical delay of 15 minutes and the case was completed with manual instrumentation.No patient injury or impact was reported and the patient is doing well after surgery.Both patient and surgeon were satisfied with the surgical outcome.Smith & nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received the complaint can be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO SURGICAL SYSTEM BE/FR/DE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11531868
• MDR Text Key: 241313120
• Report Number: 3010266064-2021-00215
• 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
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFSR120031, NAVIO BBT FOOTPEDAL.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75