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

Catalog Number PFSR110137

Device Problems Failure to Recalibrate (1517); Material Twisted/Bent (2981)

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

Event Date 11/06/2017

Event Type  Injury  

Event Description

It was reported that there was a homing failure with the handpiece; the surgical tech had issues advancing the drill with long attachment into the navio handpiece.The surgeon was ready for the case by the time they opened the third navio but the three devices failed, just aborted, and did a manual.Upon further inspection, it was found that the handpiece had a bent drill guide support and that caused the homing failure.No patient injuries reported beyond this event.

Manufacturer Narrative

H10: the device, intended for use in treatment, was not returned for investigation.The probable cause of the issue was a mechanical component failure.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history review found similar reports, this issue will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions for using the handpiece.This failure is an identified failure mode within the risk file.A relationship between the device and the reported event could not be established.No visual/functional evaluation was conducted since the device was not returned, but based upon the reported event description, this failure had been previously attributed to a mechanical component failure.A factor that could have contributed to this event is if the drill guide support was aluminum.The material has been changed to stainless steel to increase durability and reduce deformation in the field, where a corrective action has been open for this issue.However, without the actual device or photos for visual inspection to confirm the color or material of the device, the actual cause of the reported event could not be determined.Per complaint details, the device malfunctioned prior to surgical use.The surgeon changed to a manual instrumentation to complete the procedure.Based on the information provided, there was no surgical delay or patient injury/impact to the patient.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9994353
• MDR Text Key: 188838060
• Report Number: 3010266064-2020-00463
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention