MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problems Circuit Failure (1089); No Apparent Adverse Event (3189)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported that during set up for a navio assisted surgery, they received a 40000000000 error.The procedure was completed with a manual instrumentation.Patient was not harmed beyond the issue reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during the set up for a navio assisted surgery, they received a 40000000000 error.Therefore, it was decided to reschedule the surgery.Patient was not harmed as a consequence of this issue.

Manufacturer Narrative

Section h3, h6: the navio handpiece, part number pfsr110137, intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.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.Care and caution should be exercised during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to the navio surgical system user¿s manual for proper handling.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an siu failure.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: NAVIO HANDPIECE
• 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: 13191723
• MDR Text Key: 283401733
• Report Number: 3010266064-2022-00016
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2022

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: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/11/2022; 08/04/2022
• Supplement Dates FDA Received: 02/04/2022; 08/09/2022
• 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: A
• Patient Sequence Number: 1