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

Model Number	PFSR110137
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during the preparation for a navio assisted tka surgery, they got an error message during bur homing saying "internal cabling drill/console error".They unplugged the navio handpiece and rebooted the machine.After start up, they got an error saying "pfs control hardware failure".The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the navio handpiece, part number pfsr110137, sn(b)(6), used for 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 evaluation followed performance verification pv0004, rev c.The reported problem was confirmed.The handpiece would not perform the test & produced a homing error.The gear would not turn by hand.The max t1 torque was 98.No additional functional non-conformances were identified.The most likely cause of this event is mechanical failure related to the motor.The surgical technique guide provides a ¿recovery procedure guidelines¿ table that provides guidelines for recovering to a fully manual procedure.A review of manufacturing and 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.The review determined that prior escalation actions are applicable to the scope of this complaint, however, no further escalation action is required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.As a part of corrective action a design change to help reduce build up within the motor.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: NAVIO HANDPIECE
• Common Device Name: 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: 13480846
• Report Number: 3010266064-2022-00086
• Device Sequence Number: 5364179
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown