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

Catalog Number PFSR110137

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

It was reported that during a case the patient was already under anesthesia when a handpiece test was ran.The first torque reading was 34, below the threshold of 40 but still a bit high so ran the test again.Second reading was 36.Third reading was 40.Swapped to a different handpiece, initial reading was in the thirties also, second reading came to 22.Proceeded to run the case.Delay was greater than 30 minutes because the circulator didn't call up a backup tray as asked by the rep before even running the first handpiece test, had to repeatedly ask for a backup tray to complete surgery.No patient impact involved.

Manufacturer Narrative

The device used for treatment was returned for evaluation.The reported problem was not visually confirmed.Functional evaluation was performed and the reported problem was not confirmed.Completed handpiece troubleshooting test.Passed characterization 2 times.T1 = 34, 18.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 associated with the handpiece and failure mode(s) "jamming / seizing" identified similar events.A relationship between the reported event and the device could not be established as there was no damage or problem found with the device during the visual and functional inspection.As the issue stated, the results of the t1 max torque test were all below 40, which indicates the handpiece will function properly.Because there were no additional functional issues, contributing factors to the stated issue could not be identified.The reported issue could not be confirmed.No further containment or corrective actions are recommended at this time.

• 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: 9504158
• MDR Text Key: 188506644
• Report Number: 3010266064-2019-00142
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1