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

Model Number	PFSD01008
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up for a navio assisted surgery, it was notices that navio bone pin 4.0mmx152mm (case-(b)(4)), navio bone pin 4.0mm x 127mm (case-(b)(4)) and navio handpiece thumberscrew (case-(b)(4)) had lost their threadings.It is unknown if there was a surgical delay and how the procedure was completed.
Additional Manufacturer Narrative
H3, h6: the navio bone pin 4.0mm x 127mm, part number pfsd01008, lot unk and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation, or field service report.A complaint history review for similar reported/confirmed complaints has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper method of threading bone pin.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 or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO BONE PIN 4.0MM X 127MM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 12114826
• Report Number: 3010266064-2021-00505
• Device Sequence Number: 19690076
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K152574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: PFSD01008
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB00036/NAVIO SURGICAL SYSTEM INDIA