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

Catalog Number 220025

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 04/19/2018

Event Type  malfunction  

Event Description

It was reported that overcurrent error."handpiece motor control error" happened immediately after switching from "refine femur" to "cut femur" screens during a left medial zuk case.System was rebooted and surgery was completed using speed mode since the error kept showing.

Manufacturer Narrative

H3, h6: the device, used during treatment, was returned for investigation.The initial visual evaluation of the log files showed the over current error message.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.During functional evaluation of the handpiece, it did not produce an over current error, 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 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: 9993907
• MDR Text Key: 189369952
• Report Number: 3010266064-2020-00802
• 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: 04/19/2018

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?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NUMBER 220025
• Patient Age: 70 YR