MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110004

Device Problems Unintended System Motion (1430); Failure to Recalibrate (1517)

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

Event Date 09/01/2015

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, the handpiece would not calibrate because the error was above the threshold.The point probe was replaced but the error was not fixed.There were no reflective surfaces and no loose spheres affecting the calibration step.The handpiece, point probe, and drill were swapped out.After the case, the device was inspected, the customer noticed the point probe felt "loose" when it was connected to the handpiece which may have been the reason for the threshold error during calibration.35 minutes of the surgical delay was reported.No patient injuries reported beyond this event.

Manufacturer Narrative

H10: the navio handpiece (part number 110004 / serial number (b)(6)), used in treatment, had calibration issues during a procedure on (b)(6) 2015.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio handpiece was not returned for further evaluation and a visual/functional inspection was not performed.However, this handpiece was found to have been among the affected serial numbers that have been displaying the issue of 'excessive play between the handpiece and probe'.A tolerance analysis was done on the existing parts to see if there was any room for improvement of the fit between the handpiece and the calibration probe.It appears that the current tolerances provide a relatively tight fit and any attempts to tighten it up would be of minor benefit and potentially produce different issues, such as super tight fits and greater part rejection rates.The root cause of this issue was found to be manufacturing specification insufficient.This issue has been fixed with an update to the software.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9984507
• MDR Text Key: 189830431
• Report Number: 3010266064-2020-00236
• 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: 07/31/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFSR110005 NAVIO POINT PROBE