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

Model Number PFSR110137

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

It was reported that during a navio lab/demo, the handpiece failed.Its snap-lock was found faulty.It was swapped for its backup to continue.No patient was involved.

Manufacturer Narrative

H3, h6: the navio, handpiece, part number 110137, sn: (b)(6), intended for use in treatment was returned for evaluation.The reported problem was visually confirmed.The snap lock nut is detached and the set pin is missing.Although the reported problem was visually confirmed, a functional evaluation could not be performed due to broken/damaged parts.The snap lock nut is broken.No additional functional non-conformances were identified.A review of device records using the nc database, (legacy bbt, caweb4 and smartsolve) confirmed no abnormalities were reported on this device during manufacture.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is mechanical failure of the snaplock nut.Based on the investigation, no further containment or corrective action is recommended or required 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 55441
• MDR Report Key: 10875780
• MDR Text Key: 217424497
• Report Number: 3010266064-2020-02025
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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 Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1