MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110004

Device Problems Failure to Recalibrate (1517); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2017

Event Type  malfunction  

Event Description

It was reported that during the demonstration, there was unable to turn the gears in the handpiece.The customer tried adding more instrument lubricant but was unable to get them to move.The handpiece was replaced prior to start with the case.Results of investigation have concluded that the internal components of the handpiece motor have issues, causing an increased torque values, which makes it a reportable event.

Manufacturer Narrative

H10 h3, h6: the device, intended for use in treatment, was returned for evaluation.The functional inspection of the returned handpiece found that the handpiece motor could not be moved manually.The dhr was reviewed and the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar complaints of the reported issues.The relationship of the device and the reported event has been established.The motor of the handpiece was damaged but could not be further investigated as it was an off-the-shelf motor.Therefore, the root cause of the reported event was supplier/raw material fault.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9994341
• MDR Text Key: 189492859
• Report Number: 3010266064-2020-00458
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1