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

Model Number PFSR110137

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and the reported problem was confirmed.The handpiece characterization test (evaluates proper motor function) had a torque (t1) value of 98 (this value exceeds the allowed threshold value of 40).The motor could not be manually turned.The failure of the motor prevented further functional testing.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.The high torque value and inability to manually move the motor indicates that the most likely cause of this event is the failure of the motor due to the sterilization process.Further investigation into the reported failure is being conducted to determine if additional actions are required.

Event Description

It was reported that during tka admin handpiece test torque range was 98 for multiple tests.Following the test, the bur was fully extended.After opening the case and attempting to retract the bur, it remained extended.Opened a new tray and proceeded using a back-up with no issues or surgical delays.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 38116 ; 4126833844
• MDR Report Key: 10722663
• MDR Text Key: 212725251
• Report Number: 3010266064-2020-01942
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1