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 09/27/2017

Event Type  malfunction  

Event Description

It was reported a bent handpiece array prior to case.Caused the handpiece icon to flicker.Swapped arrays and problem was resolved.

Manufacturer Narrative

H10: h6: the device, intended to be used during treatment, was not returned for a prior investigation.Therefore, a visual inspection and functional testing could not be performed.However, the complaint event description stated that the handpiece tracker was bent.A factor that could have contributed to this event is 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.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.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 23 similar reports of the issue.This issue will continue to be monitored.A relationship between the device and the reported could not be established.The root cause of the reported event could not be determined.No containment or corrective actions are recommended at this time.

• 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: 9993934
• MDR Text Key: 190011711
• Report Number: 3010266064-2020-00533
• 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: 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?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR