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

Model Number PFSR110164

Device Problem Mechanical Problem (1384)

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

Event Date 12/02/2021

Event Type  Injury  

Event Description

It was reported that during a navio assisted tka surgery, the navio bone screw driver was not spinning the pins.The procedure was completed, with a non-significant delay, using a pin driver from the journey ii trays.Patient was not harmed beyond the problem reported.

Manufacturer Narrative

Internal complaint reference case (b)(4).

Manufacturer Narrative

Additional info in: d, g, h results of investigation: the navio bone screw driver (uk), pfsr110164 used for treatment was not returned for evaluation; thus, 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 is required to complete a manufacturing review.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may have been associated with a mechanical component failure and breakdown/defect of the weld.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.The surgical technique guide provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿ in the event of an unrecoverable hardware failure.This failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the united kingdom, it was reported that during a navio assisted tka surgery, the navio bone screw driver was not spinning the pins.The procedure was completed with a non-significant delay, using a pin driver from the journey ii trays.Patient was not harmed beyond the problem reported.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 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: 13060458
• MDR Text Key: 282623407
• Report Number: 3010266064-2021-00896
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110164
• Device Catalogue Number: PFSR110164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NAVIO SURGICAL SYSTEM UK/(B)(6)