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

Catalog Number 220025

Device Problem Failure to Recalibrate (1517)

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

Event Date 10/16/2017

Event Type  malfunction  

Event Description

It was reported that during the initial calibration in a ukr procedure, the system would not home.This happened twice and it repeatedly said that there might be a jam.On the third try it was successful.Once getting into the burring screen and moved to bur, the system kicked back out to re-calibrate and it then failed to home twice again.After the failure during burring, swapped handpiece and completed surgery without any other issues.

Manufacturer Narrative

The handpiece was used during treatment and returned, along with the system log files, for investigation.The system was not returned.The initial functional investigation was performed by reviewing the returned log files 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.The functional evaluation was performed on the handpiece finding no errors, which 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: 9996197
• MDR Text Key: 188856798
• Report Number: 3010266064-2020-00499
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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
• Patient Age: 72 YR