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

Catalog Number NPFS02000

Device Problem Connection Problem (2900)

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

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during the set-up for a navio assisted surgery, a navio surgical system us was unable to calibrate handpiece due to connection error.Two different handpieces were attempted and ran handpiece test on both before attempting to calibrate.Both handpieces passed initial testing but could not calibrate and burr was installed properly.Surgery was performed after a non-significant delay and changing to a manual procedure.No harm to the patient or further complications reported.

Manufacturer Narrative

Section 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.The suspect siu to handpiece chassis cable was inserted into the system.The system booted, 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 faulty handpieces.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 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 the set-up for a navio assisted surgery, a navio surgical system us was unable to calibrate handpiece due to connection error.Two different handpieces were attempted and ran handpiece test on both before attempting to calibrate.Both handpieces passed initial testing but could not calibrate and burr was installed properly.Surgery was performed after a non-significant delay and changing to a manual procedure.No harm to the patient or further complications reported.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
• 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: 15785838
• MDR Text Key: 303557923
• Report Number: 3010266064-2022-00653
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 885556628416
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention