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

Catalog Number PFSR120010

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2017

Event Type  malfunction  

Event Description

It was reported that prior to case rep found 5 handpiece arrays warped.Previous form submitted for failure during surgery, robot was aborted.

Manufacturer Narrative

H3, h6: the device, intended to be used during treatment, was returned for investigation.The visual investigation performed on 11/7/2017 found stress marks along the distal end of the thumbscrew on the handpiece tracker's connection.The device was made of aluminum material.The aluminum material that can bend more easily due to the nature of the forces placed on the handpiece tracker either via the surgeon's hand, dropping it, or any other forces.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review was performed and found 25 similar reports of the failure.This issue will continue to be monitored.A relationship between the device and the reported event could be established.The malfunction is likely due to mechanical component failure from bending of the handpiece tracker.The material has been changed to stainless steel which makes the part much stronger and less susceptible to bending, thus, reducing the likelihood of this problem.

• Brand Name: NAVIO HANDPIECE TRACKER ARRAY
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9993931
• MDR Text Key: 189755706
• Report Number: 3010266064-2020-00535
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1