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

Catalog Number PFSR110137

Device Problem Image Display Error/Artifact (1304)

Patient Problem Injury (2348)

Event Date 07/25/2018

Event Type  Injury  

Event Description

It was reported that during a surgical procedure, when was switched between exposure and speed mode an error message came up "handpiece is disconnected, the handpiece is jammed, subsystem power loss, ensure that the handpiece is not jammed and that all cables are connected".The surgeon decided to use manual instrumentation.No patient injuries reported beyond this event.Results of investigation have concluded that the devices were not returned, however, upon review of the log files, it was determined that the errors were jam detection errors caused by user error.The jam detection errors are indicative of entering cut mode while in speed control and with the handpiece still connected to the point probe, when the handpiece tries to extend the bur to its full exposure, the bur comes into contact with the plate at the point probe prior to reaching full exposure and thus throwing jam detection error.

Manufacturer Narrative

H10: the device was used during treatment but was not returned for evaluation.The log files were returned for review and indicated that a jam detection occurred.The dhr was reviewed and found that the device met the manufacturing specifications.A complaint history review found similar complaints of the reported issue and 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.It states "reasons for failure could include the following: handpiece not in point probe or jammed or drill has missing or poorly installed bur.Press "dismiss and re-home the handpiece.Repeat the homing process several times as necessary until homing succeeds.You must successfully home the handpiece before you proceed.If homing fails repeatedly, try using a new bur.If homing still fails, try using a new handpiece.".This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.The log files indicated that a jam detection error had occurred, which likely occurred after the user dismissed the warning alerting of the active handpiece without removing the point probe from the handpiece.Therefore, the root cause of the reported event was due to user error.Per complaint details, the device malfunctioned during use.Based on the information provided, there was no surgical delay or patient injury/impact as the procedure was aborted and changed to manual instrumentation; 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: 9997236
• MDR Text Key: 188886741
• Report Number: 3010266064-2020-00683
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85