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

Model Number PFSR110164

Device Problem Solder Joint Fracture (2324)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted ukr surgery, the surgeon used a navio bone screw driver and the driver broke.All the pieces were retrieved and nothing fell in the patient.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed due to the reported problem.

Manufacturer Narrative

H3, h6: the navio bone screw driver pn pfsr110164 , lot8016483, 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.Under a magnifier it was observed cracks in the weld.Functionally, 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.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.An historical capa, nc, hhe/pra, field action review was completed.A review of prior escalation actions determined this case and associated lot or serial number is associated with capa200070 and no further action is required.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.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
• Type of Device: 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: 12974530
• MDR Text Key: 284831409
• Report Number: 3010266064-2021-00859
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110164
• Device Catalogue Number: PFSR110164
• Device Lot Number: 8016483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROB20000/CORI ROBOTICS USA