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

Catalog Number 110137

Device Problem Defective Component (2292)

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

Event Date 08/16/2018

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, when the surgeon was doing distal burring, the drill kept popping out of the back of the handpiece.This occurred several times.The drill was reconnected and re-homed in order to continue with the case.No surgical delay or patient injury reported.Results of the investigation have concluded that the snaplock assembly has incorrect dimensions, which makes it a reportable event.

Manufacturer Narrative

H10: h3, h6: the navio handpiece intended for use in treatment, had an issue with the drill unlocking and failing out of the handpiece during a procedure.The impact on the case was inconvenience and the user intervened to recover and complete the case.The device was being used on a patient during the reported event and no injuries were reported.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.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.A drill attached to the handpiece and detached, as expected.It was not overly easy to unsnap the drill.The reporter did not return the drill that had the issue with the returned handpiece.Additionally, it was noted that the distance above the wave spring and down to the plunger holder was measured around the circumference of the snap lock.This was not within the specification for this dimension.Hence, the part does not conform to its design specifications.The root cause of this issue was found to be supplier / raw material fault.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9999002
• MDR Text Key: 189187231
• Report Number: 3010266064-2020-00694
• 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
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1