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

Catalog Number PFSR110137

Device Problems Failure to Recalibrate (1517); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2015

Event Type  malfunction  

Event Description

It was reported that prior to the case starting, after handpiece calibration, the drill would not home, an error appeared indicating that there was a homing failure.All components were checked in order to know if they are correctly assembled but the error persisted.The handpiece was opened but it was not possible to move the gears.The handpiece was replaced to continue with the case normally.No surgical delay or patient injury was reported.Results of the investigation have concluded that the snaplock assembly was damaged, which makes it a reportable event.

Manufacturer Narrative

H10 h3, h6: the navio handpiece, intended for use in treatment, had homing failure during testing.The navio handpiece was not returned for further evaluation and a visual/functional inspection could not be performed.During an internal analysis, the problem was determined to be caused by the material used to manufacture one of the snap lock components.The material used by one of the suppliers is displaying properties after autoclave sterilization that may cause the snap lock assembly to become tight.This handpiece had a snap lock from one of the affected lots.The root cause of this issue was found to be supplier/raw material fault.A device history record review found the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports.

• 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: 9984509
• MDR Text Key: 188670838
• Report Number: 3010266064-2020-00234
• 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: PFSR110137
• 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
• Patient Age: 65 YR