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

Model Number PFSR100026

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the thumb screw was broken.There was no delay of surgery nor health consequence to the patient.

Manufacturer Narrative

The navio handpiece thumbscrew, used in treatment, was returned for further evaluation and a visual evaluation was performed, which confirmed the reported problem.The thumbscrew shaft is completely broken into two pieces.A functional evaluation could not be performed due to broken/damaged parts.A device history record review found no conditions which could contribute to the reported event and 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.The root cause was found to be user error.No containment or corrective actions are recommended at this time.To prevent a recurrence of the issue, and for proper care/maintenance and usage of the device, refer to navio surgical system for total knee arthroplasty user¿s manual, as it provides instructions on the proper techniques of tightening the thumbscrews.Correction on d10.

• 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: 9994797
• MDR Text Key: 188857763
• Report Number: 3010266064-2020-01295
• 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: 08/17/2020

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 Model Number: PFSR100026
• Device Catalogue Number: PFSR100026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 08/12/2020
• Patient Sequence Number: 1