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

Model Number PFSR100026

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

It was reported that at the end of the tka procedure, while disassembling the handpiece, the thumbscrew on the handpiece tracker array broke.No patient was involved in the moment.No other complications were reported.

Manufacturer Narrative

The navio handpiece thumbscrew, part pfsr100026 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor could be over tightening with excessive force by the user.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• 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: 10411805
• MDR Text Key: 203121206
• Report Number: 3010266064-2020-01710
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556648421
• UDI-Public: 00885556648421
• Combination Product (y/n): N
• PMA/PMN Number: K160537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2020
• 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?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1