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

Catalog Number PFSR110137

Device Problem Electrical Shorting (2926)

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

Event Date 03/14/2019

Event Type  malfunction  

Event Description

It was reported that there was an internal cabling error during a case.Drill and handpiece were removed, reinserted, recalibrated when necessary and surgery was completed after a delay of unknown length.The patient was not harmed.The preliminary assessment of the device indicates that a short circuit in the handpiece blew a fuse in the siu, which is a reportable malfunction.

Manufacturer Narrative

H10: the device was used during treatment and was returned for investigation.The initial functional evaluation of the handpiece found there was a short in the cabling that caused the blown fuse in the siu.The device history record (dhr) was reviewed for this device and was found to meet specification.A complaint history review found a total of 24 complaints of the reported issue and will continue to be monitored.The relationship of the device and the reported event has been established.The blown fuse was due to a short in the handpiece cabling.The root cause of the reported event was due to an electrical component failure.We are further investigating this issue and have opened a corrective action.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2828 liberty ave; suite 100; pittsburgh, pa
• MDR Report Key: 9998652
• MDR Text Key: 189452080
• Report Number: 3010266064-2020-01069
• 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: 08/10/2020

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: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1