MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 110137

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2019

Event Type  malfunction  

Event Description

It was reported that during a demo procedure, the system continuously displays a hardware error message.After inspection, was found that the siu was not functioning according to specification.The surgeon decided to use manual instrumentation to continue with the demonstration.Results of the investigation have concluded that the handpiece has an electrical issue in either motor itself or the wiring along the cable that is causing a short circuit that affecting the siu, which makes it a reportable event.

Manufacturer Narrative

H10: the device was used during treatment and was returned for investigation.The initial functional evaluation of the handpiece found there was an electrical short in the cabling causing a blown fuse in the siu.The dhr could not be reviewed and it was not confirmed whether the product met manufacturing specifications.A complaint history review found similar complaints and this issue will continue to be monitored.The relationship of the device and the reported event has been established.The blown fuse was due to a short in the handpiece cabling.The root cause of the reported event was due to an electrical component failure.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9995658
• MDR Text Key: 188897442
• Report Number: 3010266064-2020-01019
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 220025; 220025
• Patient Outcome(s): Required Intervention