MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSD01008

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  malfunction  

Event Description

It was reported that, during an unspecified surgery, the bone pin was noticed as bent.A bone pin, from an alternative set, was used to perform the procedure.Surgery was not delayed.The patient was not harmed.

Manufacturer Narrative

The device, was intended for use for treatment.Visual inspection confirmed that the bone screw was bent.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review identified similar events.This failure mode will be trended to assess for any necessary corrective actions.We were able to confirm there was a relationship established between the reported event and the device.The malfunction is due to the user allowing the weight of the drill to fall while attached to the screw.The bone pin can also bend if it is held rigidly in place during removal and if the user allows the weight of the drill to fall while being attached to the pin.Typically, this occurs if the tracker clamp and tracker is not removed before taking the pin out.No containment or corrective actions are recommended at this time.

• Brand Name: NAVIO BONE PIN 4.0MM X 127MM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9986318
• MDR Text Key: 188517829
• Report Number: 3010266064-2020-01216
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSD01008
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1