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

Model Number PFSR110137

Device Problem Connection Problem (2900)

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

Event Date 11/05/2019

Event Type  malfunction  

Event Description

It was reported handpiece would not communicate with system during initial segment of distal femur. I tried to reboot system and it did not work so i replaced hand piece and it worked. After case performed troubleshooting for handpiece and it wouldn¿t connect for that either. No patient injuries involved and delay greater than 30 minutes was reported.

Manufacturer Narrative

The device used for treatment was returned for evaluation. The reported problem was visually confirmed. The snap-lock nut is sheared off at the collet. In addition, a visual inspection was performed on the part beyond the reported complaint. The snap locknut is the old version without the pin. Although the reported problem was visually confirmed, a functional evaluation was performed and failed the handpiece test with a t1 value of 98. 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) "error message(s)" identified similar events. The most likely cause of this event is the mechanical failure of the snap lock. As a part of corrective actions, more robust design of the snap lock 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 55441
• MDR Report Key: 9407421
• Report Number: 3010266064-2019-00137
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K180271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No