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

Catalog Number PFSR110137

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Event Description

It was reported that, during an ukr surgery, while homing an error message appeared on screen.On inspection, it was noted that the handpiece gears did not move and appeared fixed in place.Another handpiece was used to resume the procedure.Surgery was delayed, but it is unknown for how long.The patient was not harmed.The result of investigation indicates that the motor is internally damaged.

Manufacturer Narrative

H10 h3, h6: the device was intended to be used during treatment and was returned for a prior investigation.The initial functional inspection of the returned device found that the internal components of the handpiece motor had begun to deteriorate/fail, causing the increased torque values and the subsequent homing failures.The device history record was reviewed finding that 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 handpiece likely had internal motor issues which caused the reported event.However, the motor is an off-the-shelf device manufactured by a supplier.Therefore, the root cause of the reported event was due to raw material/supplier fault.

• 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: 9993599
• MDR Text Key: 190013274
• Report Number: 3010266064-2020-00614
• 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,foreig
• 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: 04/23/2020
• 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
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1