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

Catalog Number PFSR110137

Device Problems Break (1069); Failure to Recalibrate (1517)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

It was reported that during the pre-inspection of the handpiece before the case, it was noticed that the stabilizing rubber component that interfaces with the snaplock and worm screw had disassociated from the snaplock.The handpiece was replaced to continue with the case.The device was not being used with a patient during the event.Results of the investigation have concluded that the snaplock assembly was broken, which makes it a reportable event.

Manufacturer Narrative

H10 h3, h6: the navio handpiece, intended for use in treatment, had a handpiece error during cut mode prior to a procedure.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The log files indicate a jam detection of the navio handpiece.Evaluation of the returned handpiece showed that the lead screw was damaged and caused the jam in the handpiece.The navio system checks for jam detection and accurately recognized the problem, stopping the procedure with an error.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; suite 40; plymouth, mn
• MDR Report Key: 9994347
• MDR Text Key: 189763134
• Report Number: 3010266064-2020-00467
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

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: PFSR110137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1