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

Catalog Number 220025

Device Problem Defective Component (2292)

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

Event Date 10/02/2018

Event Type  malfunction  

Event Description

It was reported that relevant idb was installed for australia and enabled tka on the brand new unit with no issues.Switched on the unit to the error message "pfs control hardware failure (errcode = 40000000000)." checked all physical usb connections to the corvalent pc, checked the power switch on the siu, reinstalled the application software, recalibrated the touch screen, reinstalled the implant database, enabled tka and reinstalled the language pack to no avail.

Manufacturer Narrative

H10: the device, intended to be used during treatment, was returned for investigation.Functional inspection of the returned siu found that the device received a 40000000000 error message when powered on.This confirms the fuse in the siu was blown.The device history record for this device was reviewed and found to pass all inspection tests.Therefore, the reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports of the issue.This issue will continue to be monitored.There has been a corrective action opened to address this issue and it is being further investigated.The relationship of the device and the reported event has been established.The error message was caused by a blown fuse in the siu.The root cause of the reported event was due to 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: 9993905
• MDR Text Key: 190179671
• Report Number: 3010266064-2020-00806
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1