MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR120010

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 02/03/2017

Event Type  malfunction  

Event Description

During femur cutting, surgeon commented that he thought he was cutting way too much from the posterior femur; however, the bone model did not turn red.Prior to entering cutting, the femur checkpoint passed, so we were not concerned about the femur tracker's rigidity.Just after he commented about the depth, we switched to speed control and went back to planning to double check our posterior femur cut depth.The cut seemed well aligned with the mesh.When the scrub tech handed dr.Carangelo the handpiece, the tracker came off.

Manufacturer Narrative

The device, used in treatment, was not made available to the designated complaint unit for independent evaluation, therefore, visual inspection and functional evaluation of the device could not be performed.The initial investigator found that after discussion with the customer, the handpiece tracker came off possibly due to ineffective equipment set up by the or staff.It was suggested that the customer ensures that the handpiece tracker was tightened with the t-wrench prior to the case starting.The serial number was not provided.Therefore, the reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports of the event.The surgical technique guide released at the time of the complaint provides instructions on the administrative and preoperative procedures.It states in the warning: if at any point during the procedure, you observe that the handpiece tracker array has become loose, tighten the tracker array to the handpiece and recalibrate the handpiece (page 42).The instructions for use contains information, which helps to prevent the reported occurrence.The user likely did not follow the instructions for use.This failure is an identified failure mode within the risk file.Based upon the reported event, we cannot confirm that there was a relationship between the reported event and the device.Factors that may have contributed to the reported event could be lack of efficient operator training and improper equipment set up.Therefore, the root cause of the reported device issue could not be determined.

• Brand Name: NAVIO HANDPIECE TRACKER ARRAY
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993928
• MDR Text Key: 188841234
• Report Number: 3010266064-2020-00531
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention