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

Catalog Number PFSR110137

Device Problems Mechanical Problem (1384); Failure to Calibrate (2440)

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

Event Date 11/07/2016

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, the handpiece did not calibrate.Troubleshooting was performed and the actual issue seemed to be that the snap lock cog wheel was completely stuck.After lubricating the wheel, it could not be turned.Also, when the speed guard was out onto the handpiece, it did not lock all the way into the locking piece: it locked in, but not all the way, as if the lock was stuck in the down motion.The tibia was manually cut.The surgical outcome was great.

Manufacturer Narrative

H10: the device was used during treatment and was returned for a prior investigation.The functional inspection of the returned handpiece found that after autoclaving and cooling down, the handpiece motor required higher than normal torque to move after sterilization.The dhr was reviewed and the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found a total of 3 complaints of the reported issues and it will continue to be monitored.The surgical technique guide released at the time of the complaint provides a warning statement on what to do when there is a homing failure.This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.After sterilization, the handpiece will require a higher torque to move in characterization.Typically, we have seen that the motor will break free and become operable after a second or third characterization test.The root cause of the reported event was due to mechanical component failure.Per complaint details, the device malfunctioned during use and the navio was abandoned for manual instrumentation.Based on the information provided the modified procedure did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9984543
• MDR Text Key: 188644929
• Report Number: 3010266064-2020-00323
• 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,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 Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR