MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 110137

Device Problems Defective Component (2292); Electrical Shorting (2926)

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

Event Date 06/07/2019

Event Type  malfunction  

Event Description

It was reported that, during an unspecified surgery, there was a "handpiece exposure control motor failure" error displayed on screen.The user was able to dismiss the error, recalibrate and rehome the handpiece.Surgery was delayed less than 30 min.The patient was not harmed.The results of investigation show that the handpiece had an internal wiring damaged that caused an electrical short, which is a reportable malfunction.

Manufacturer Narrative

H3, h6: the device used during treatment was returned for investigation.The initial functional evaluation of the handpiece found there was a short in the cabling.The dhr was reviewed and the product met manufacturing specifications.A complaint history review found similar complaints.The relationship of the device and the reported event has been established.There was a connectivity issue at the handpiece end of the cable.The internal wiring at that end had come apart in the cable, causing a short in the cable and the "handpiece exposure control motor failure" error to appear.The root cause of the reported event was due to an electrical component failure.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9998933
• MDR Text Key: 189323511
• Report Number: 3010266064-2020-01044
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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: 110137
• 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: 66 YR
• Patient Weight: 83