MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MMX152MM

Model Number	ROB00031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up for a navio-assisted surgery, it was found that the navio bone pin 4.0mmx152mm was broken.The procedure was finished with a smith and nephew back up device without delays.The patient was not harmed.
Additional Manufacturer Narrative
The navio bone pin pn rob00031, use in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirm, factor that may have contributed to the reported symptom may have been associated with mishandling.Care and caution should be exercised during the surgical site setup and tear down to protect the pin from an unforeseen force, such as falling onto a hard surface or damage during transport.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO BONE PIN 4.0MMX152MM
• Common Device Name: NAVIO BONE PIN 4.0MMX152MM
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11921261
• Report Number: 3010266064-2021-00435
• Device Sequence Number: 17253133
• Product Code: OLO
• UDI-Device Identifier: 00885556685310
• UDI-Public: 00885556685310
• Combination Product (Y/N): N
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: ROB00031
• Device Catalogue Number: ROB00031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1