MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110006

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  malfunction  

Event Description

It was reported that, during a demonstration of a unicondylar knee replacement, the burr did not spin freely in the long attachment for there was lack of irrigation.This problem caused both overheating of the long attachment and an e2 error when the burr eventually stopped working.After troubleshooting by exchanging the burr and re-starting the system, the problem was not solved.No patient was involved.

Manufacturer Narrative

The device (one of one) intended for use in treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing records could not be performed as no serial number was provided.A complaint history review for similar reported/confirmed complaints associated with the device and failure mode(s) "overheating" identified similar events between (b)(6) 2020 and (b)(6) 2017.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been internal damage to the bearings causing the bur not to pass through.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO LONG ATTACHMENT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10016193
• MDR Text Key: 189576661
• Report Number: 3010266064-2020-01569
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110006
• Device Catalogue Number: PFSR110006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFSR101209, HANDPIECE,EMAX2PLUS(ANSPACHDRILL).; PFSR101209, HANDPIECE,EMAX2PLUS(ANSPACHDRILL)