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

Model Number PFSR100026

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2020

Event Type  malfunction  

Event Description

It was reported that, before navio ukr procedure, while the scrub technician was tightening the handpiece thumbscrew, the thumbscrew broke.The procedure was completed without delay with a equipment swap.No patient harm or additional complications were reported.

Manufacturer Narrative

H3, h6: the navio thumbscrew p/n 100026 intended for use in treatment was returned.The reported problem was visually confirmed.The thumbscrew is broke in half.Although the reported problem was visually confirmed, a functional evaluation could not be performed due to broken/damaged parts.The thumbscrew is broken in half.A review of device records using the nc database(s), (legacy bbt, caweb4 and smartsolve) confirmed no abnormalities were reported on this device during manufacture.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is over tightening with excessive force by the user.Per the navio surgical system user's manual "to close and lock the clamshell, it is recommended to twist the thumbscrew by hand clockwise, until it is tightened securely." to attach the handpiece tracker, twist the thumbscrews clockwise by hand and then use the t-handle wrench to tighten the thumbscrews until the handpiece tracker array is firmly attached to the handpiece.Note: do not overtighten the thumbscrews." although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

• Brand Name: NAVIO HANDPIECE THUMBERSCREW
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10835463
• MDR Text Key: 216141243
• Report Number: 3010266064-2020-01994
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556648421
• UDI-Public: 00885556648421
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR100026
• Device Catalogue Number: PFSR100026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1