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); Intermittent Communication Failure (4038)

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

Event Date 05/14/2019

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, a hand piece test prior to calibration was performed and received an error that the navio could not communicate with the cables.It was tried to calibrate, but it kept receiving a hand piece error.Since it was not able to complete calibration, the case was converted to manual technique.The patient outcome is unknown.The results of investigation indicate that the connection was intermittent and there was an over current error, further confirming the internal wiring damage.

Manufacturer Narrative

H10: h3, h6: the device, used in treatment, was returned for investigation.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.The surgical system user's manual released at the time of the complaint (pn 500097 rev e) provides complete and detailed instructions for handpiece cable connection and maintenance.This is an identified failure mode within the risk assessment.We could confirm there was a relationship established between the reported event and the device.Visual inspection of the handpiece cable showed that it was damaged outside of normal use.The strain relief of the cable had been pulled all the way from the handpiece end of the cable to the connector end.It is likely that with the strain relief pulled away, the cable at the handpiece end experienced more strain from use, causing the internal wiring to break.Review of the log files found that there were overcurrent errors throughout the case.The handpiece was connected to a system and the cable was manipulated during homing.The connection was intermittent and review of the log files found that there was an over current error, further confirming the internal wiring damage.The root cause was established to be user error.

• 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: 9998928
• MDR Text Key: 188929564
• Report Number: 3010266064-2020-01039
• 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: 08/21/2020

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention