MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number NPFS02000

Device Problems Power Problem (3010); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  Injury  

Event Description

It was reported that, while burring the distal femur in a navio tka procedure, the anspach drill would not spin.They took apart the long attachment and bur to reassemble, but this did not work.They also unplugged the foot pedal and drill separately, but it did not work either.They also had to recalibrate, but the issue was not resolved.It looked like the handpiece was working, but the anspach drill just would not spin.The surgery was changed to manual procedure with a delay of fewer than 30 minutes.After the case, they tested the drill multiple times and it worked perfectly.There was no problem with either drill pedal or drill.No other complications were reported.

Manufacturer Narrative

The navio surgical system us, part number npfs02000, serial number sn (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.Log files although submitted would have no information to add to the investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the navio surgical system user¿s manual, section intraoperative workflow: patient and system setup, assembling the surgical drill for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a drill motor 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 SURGICAL SYSTEM US
• 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: 10875395
• MDR Text Key: 217330549
• Report Number: 3010266064-2020-02020
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: CNSL, EMAX 2 PLUS, ANSPACH, ROHS CMPLNT; CNSL, EMAX 2 PLUS, ANSPACH, ROHS CMPLNT
• Patient Outcome(s): Required Intervention