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

Catalog Number	NPFS02000
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a navio assisted pfa surgery, they received an "unable to communicate with handpiece" message with three different navio handpieces.The procedure was completed with manual instruments without delay.The patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the navio surgical system siu, p/n 220025, s/n (b)(6) (us), intended for use in 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 siu was inserted into a known functioning navio system.The system booted with no issues.A functioning handpiece connected and calibrated with no errors.Although the reported problem was not confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may have been associated with a known firmware bug.A review of manufacturing records indicate the software 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 navio surgical technique guide for knee arthroplasty provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that during a navio assisted pfa surgery, they received an "unable to communicate with handpiece" message with three different navio handpieces.The procedure was completed with manual instruments without delay.The patient was not harmed.Although no further containment or corrective action is recommended or required at this time, 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
• 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: 14645426
• Report Number: 3010266064-2022-00471
• Device Sequence Number: 5109258
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 11/29/2022

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 Catalogue Number: NPFS02000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 11/29/2022
• 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: Required Intervention
• Patient Sex: Unknown