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

Model Number PFSR110137

Device Problem Mechanical Jam (2983)

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

Event Date 08/19/2020

Event Type  Injury  

Event Description

It was reported that before a navio tka procedure, the handpiece failed a handpiece test five times.The torque was too high and it did not complete the cycle.The procedure was changed to manual tka since there weren't any other sterile trays available.There was no delay in the procedure.No other complications were reported.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) contains instructions for proper handpiece assembly in the "assembling the hardware" section and handpiece testing in the "performing handpiece diagnostics" section.The navio surgical technique guide (500197) provides instructions for reverting to a manual procedure at any point in the case in the "recovery procedure guidelines" section.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to the reported event could be if the handpiece had the torque issue where the motor is seized after sterilization and needs to be run through characterization to clear it.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

G3, h2, h3, and h6: the navio, handpiece, part number 110137, s/n (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The long attachment fit very tight & the pin gauges would not fit into the drill guide.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.The most likely cause of this event is mishandling during shipping, storage, use or reuse of the device, wear and tear over time.The use of care and caution should be exercised during the surgical site setup and teardown to protect the drill and handpiece cable from sharp objects or from situations that pin the cable between two objects.Do not use excessive force on the drill and handpiece strain reliefs during the decontamination process to minimize separating the cable from the strain relief.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.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
• MDR Report Key: 10551959
• MDR Text Key: 207505379
• Report Number: 3010266064-2020-01773
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NAVIO SURGICAL SYSTEM US/UNKNOWN
• Patient Outcome(s): Required Intervention