MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR110164
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during set up for a navio assisted tka surgery, the navio bone screw driver was broken and would not hold the navio pins properly.The procedure was completed, without delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Section: h3, h6: the navio pin driver pn pfsr110164, lot #8016483, use in treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually and functionally confirmed.The pin driver have cracks in the weld of the tool.A functional evaluation was performed.The pin driver was attached to the bone pin to intend proper operation of the component.The pin driver wouldn't engaged and rotated the bone pin.No additional functional non-conformances were identified.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is mechanical component failure and breakdown/defect of the weld.Further investigation into the reported failure has been conducted, and the potential root cause is a combination of durability issues after extended use (expected wear and tear rate), abnormal use of the tools, or inherent variations in the manual weld process that are present across production lots.The investigation was closed with appropriate risk justification and objective evidence that led to the potential root causes listed above.Based on the investigation, no additional containment or corrective actions are recommended at this time.

• Brand Name: NAVIO BONE SCREW DRIVER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12725466
• Report Number: 3010266064-2021-00736
• Device Sequence Number: 13842601
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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: PFSR110164
• Device Catalogue Number: PFSR110164
• Device Lot Number: (10)8016483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 10/30/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NPFS02000-NAVIO SURGICAL SYSTEM US
• Patient Sex: Unknown