MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SIU; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 220025

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

It was reported that during a case the "handpiece exposure control motor failure" error appeared.At the beginning of the case, the handpiece calibrated as expected on the first try.The drill also homed as expected on the first try.The case proceeded as expected until entering into cutting.Doctor refined the femur (in exposure control), and then switched into cut femur.Almost immediately after pressing the foot pedal, the exposure control error appeared.Forced to recalibrate and rehome, which were able to do successfully on the first try.Went back into cutting, and the same thing happened again.When moving back to the handpiece connect stage, the handpiece was unplugged and plugged back in.Calibrated and homed the handpiece and drill one more time and were successful on the first try.Back-up device was available but the entire bone resection was completed in speed control, and the error did not reappear.

Manufacturer Narrative

The device was used in treatment and the log files were returned for evaluation.Evaluation of the returned log files was performed which showed an "over current" error.When the error can only be cleared by rebooting the system, it is indicative of an issue in the siu firmware that randomly causes the handpiece error message and is not indicative of an issue with the handpiece.This confirms the issue in the siu.There was no serial number provided for the dhr review of the siu so it could not be concluded if the device met the manufacturing specifications.A complaint history review found similar reports of the issue.The relationship of the device and the reported event has been established.The over current error that occurred was due to an issue in the siu.As a result, the root cause of the reported event was due to an electrical component failure.

• Brand Name: SIU
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest; blvd ste 40; plymouth, mn
• MDR Report Key: 9994080
• MDR Text Key: 189154496
• Report Number: 3010266064-2020-00249
• 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
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 220025
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1