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

Catalog Number PFSR110137

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

It was reported that, during an unspecified surgery, the black stopper on inside of the handpiece is broken and did not stay attached: it was spun so it could temporarily lock into the metal, allowing to properly calibrate the handpiece and continue with the case.Surgery was not delayed.The patient was not harmed.

Manufacturer Narrative

The navio handpiece (part number 110137 / serial number (b)(6)), intended for use in treatment, had a broken snap lock nut prior to a procedure on (b)(6) 2018.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 navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The snap lock nut was broken and detached from the rest of the snap lock.The root cause of this issue was found to be mechanical component failure.As part of corrective actions, a new and more robust design of the snaplock has been released.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9988787
• MDR Text Key: 188643228
• Report Number: 3010266064-2020-00620
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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: 03/05/2018
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1