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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 110137
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2019
Event Type  Injury  
Manufacturer Narrative
It was reported that during a tka procedure, after planning and moving to the cutting phase, doctor was attempting to bur when he received an error claiming there was a handpiece exposure control motor failure.He would dismiss and be kicked back to calibration, but after each time the system would still present with the same error.The recon rep checked the connections on the handpiece and system and could not see any issues there either.The scrub tech also attempted to disassemble and reassemble the handpiece, but had no change.Doctor continue by using the saw and the visualization tool to ensure his cuts were as accurate as can be without the of the bur.There was a delay greater than 30 minutes.Investigation results confirm the connection was intermittent and review of the log files on the system found that there was an over current error, confirming internal wiring damage.This also indicative of bug 1469.
 
Event Description
It was reported that during a tka procedure, after planning and moving to the cutting phase, doctor was attempting to bur when he received an error claiming there was a handpiece exposure control motor failure.He would dismiss and be kicked back to calibration, but after each time the system would still present with the same error.The recon rep checked the connections on the handpiece and system and could not see any issues there either.The scrub tech also attempted to disassemble and reassemble the handpiece, but had no change.Doctor continue by using the saw and the visualization tool to ensure his cuts were as accurate as can be without the of the bur.There was a delay greater than 30 minutes.Investigation results confirm the connection was intermittent and review of the log files on the system found that there was an over current error, confirming internal wiring damage.This also indicative of bug 1469.
 
Manufacturer Narrative
H10 h3, h6: the device was used during treatment and was returned for investigation.The initial functional evaluation of the handpiece found that there was short in the cabling.The dhr was reviewed and the product met manufacturing specifications.A complaint history review found similar complaints of the reported issues and will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable, etc.Since the issue was due to component failure, product labeling has been ruled out as a cause of the complaint.This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.The short in the handpiece cabling caused the blown fuse in the siu.The root cause of the reported event was due to electrical component failure.
 
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Brand Name
HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9995662
MDR Text Key189833828
Report Number3010266064-2020-01026
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number110137
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
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