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

Catalog Number PFSR110137

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 08/20/2018

Event Type  Injury  

Event Description

It was reported that during a tka procedure, after doing the distal burring on the femur and the holes on the tibia with the 5 mm conical burr, surgeon wanted to change to a 2 mm burr for the rotation holes in the femur and started to have problems.An error message appeared.Everything was checked: the burr and cables where all well connected.There was a loop and could not go out: could not manage to go to the screen with the femur and tibia for burring.Each time dismiss was pressed it went back to the screen to choose the burr.There was surgical delay reported and the procedure was converted to manual.

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.There was no serial number provided for the dhr review so it could not be concluded if 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, as the user aborted the procedure and changed to manual instrumentation; there was no surgical delay or patient injury/impact reported.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: 9993769
• MDR Text Key: 188838776
• Report Number: 3010266064-2020-00863
• 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

• Date FDA Received: 04/23/2020
• 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: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention