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

Model Number	PFSDV0016
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a navio ukr procedure, after implant planning when the surgeon wanted to burr the femur, the message handpiece exposure control motor failure appeared.They opened another navio set instrument to swap the handpiece to continue the procedure without issues.There was a delay of 10 minutes.After the surgery, both handpiece and anspach were tested and were fine.No other complications were reported.
Additional Manufacturer Narrative
The navio handpiece p/n 110004, s/n (b)(6) used for treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The "could not communicate with handpiece error" appeared at the start of the handpiece test.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 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 tear down 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.Based on the investigation, no further containment or corrective action is recommended or required at this time.

• Brand Name: NAVIO HANDPIECE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10432027
• Report Number: 3010266064-2020-01723
• Device Sequence Number: 14039384
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFSDV0016
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CN: NPFS02020, SN: (B)(4)