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

Catalog Number PFSR110137

Device Problem Failure to Calibrate (2440)

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

Event Date 11/22/2016

Event Type  malfunction  

Event Description

It was reported that, during an unspecified surgery, it was received a handpiece error as cutting was started.After trying to recalibrate three different times, the bur extended to the probe bar and then slowly retracted each time.The handpiece was replaced and the case was resumed after 5 min.The patient was not harmed.Results of the investigation have concluded that the snaplock assembly was damaged, which makes it a reportable event.

Manufacturer Narrative

The navio handpiece, used in treatment, had homing failures during a procedure on (b)(6) 2016.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.Upon opening the snap lock, it was clear that the lead screw nut had become unthreaded from the drill carrier.This does not allow the carrier to travel' as far as needed to pass homing.The epoxy on the nut was exclusively contained in the area between the visible portion of the nut and the external threads of the nut.The appropriate place for the epoxy is on the external threads to function as a thread locker.The cause of the lead screw nut to become unthreaded could be one of two possible scenarios: 1) the nut would could have been manually unthreaded by a user or 2) the nut could have become unthreaded during cutting or characterization through motor movement and the momentum provided by the weight of the drill.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: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9984551
• MDR Text Key: 188671475
• Report Number: 3010266064-2020-00326
• 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?: Yes
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR