MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110006

Device Problems Break (1069); Misassembly by Users (3133)

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

Event Date 05/12/2021

Event Type  Injury  

Event Description

It was reported that, during a navio-assisted tka surgery, the navio long attachment made it difficult to insert the spherical drill into its place and lock it on the handpiece.The procedure was finished with manual instrumentation without significant delays (fewer than 30 minutes).The patient was not harmed.

Manufacturer Narrative

H3, h6: the navio long attachment (poland), product: pfsr110006, used in treatment was not made available to the designated complaint unit for evaluation, however visual inspection was possible with 4 photos.A relationship between the reported event and the device could not be visually confirmed through photos as only the exterior was shown.A functional evaluation could not be performed because the device was not returned.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.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been associated with mechanical component failure of the bearings due to natural wear and tear.Refer to the navio surgical technique guide (500197) that provides guidelines for recovering to a fully manual procedure from a system failure.This failure is an identified failure mode within the risk assessment.There was a surgical delay of 30 minutes or less and the case was completed with manual instrumentation.No patient injury or impact was reported and it was noted that the patient is recovering well following surgery.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 LONG ATTACHMENT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11891111
• MDR Text Key: 252902886
• Report Number: 3010266064-2021-00420
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (y/n): N
• PMA/PMN Number: K160537
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFSR110006
• Device Catalogue Number: PFSR110006
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention