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

Model Number PFSR110137

Device Problem Mechanics Altered (2984)

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

Event Date 06/07/2021

Event Type  malfunction  

Event Description

It was reported that, when they started burring the femur in a navio-assisted surgery, they got an error that displayed "handpiece pfs motor failure message" while using the navio handpiece.A back up handpiece was used, but the same error was displayed.So, they quit the case, re-entered it and proceed without any issues.The procedure was completed without significant delay (3 minutes), and patient was not harmed.

Manufacturer Narrative

H3, h6: the navio handpiece, pfsr110137, sn (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.The handpiece completed the admin screen self test without any errors.A mock case was completed and no errors presented.Although the reported problem was not confirmed through a visual or functional evaluation, a factor that may have contributed to the reported symptom may have been associated with an siu firmware bug that would have corrected itself following the next system reboot.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.

• 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: 12044089
• MDR Text Key: 258976816
• Report Number: 3010266064-2021-00472
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152574
• 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: 12/07/2022

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
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/07/2022
• 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: A
• Patient Sequence Number: 1