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 11/01/2017

Event Type  malfunction  

Event Description

It was reported that during the pre-inspection of the handpiece, the stabilizing rubber component that interfaces with the snaplock and worm screw had disassociated from the snaplock.The handpiece was replaced in order to start 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: the navio handpiece (part number 110137 / serial number (b)(6)), intended for use in treatment, had an issue with lead screw nut separating from the snap lock prior to a procedure on (b)(6) 2017.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The lead screw nut was broken at the threads indicating an attempt to move the nut independent of the snap lock body (aka drill carrier).This is most likely caused by outside forces (user/scrub tech/cpd personnel) attempting to "move the gears" and mistaking the lead screw nut for the portion they want to exercise.The root cause of this issue was found to be user error.A device history record review found the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.To prevent a recurrence of the issue, and for proper care/maintenance and usage of the device, refer to the navio surgical system instrument kit guide to cleaning and sterilization and navio surgical system for unicondylar knee replacement and patellofemoral arthoplasty user's manual.

• 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: 9994342
• MDR Text Key: 189911046
• Report Number: 3010266064-2020-00460
• 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: 08/04/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1