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	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during set up for a navio tka surgery, the unit displayed error messages for foot pedals and handpiece.They did usual cascade of reboots, resets, plug/unplug.Ultimately the 4000000000 error code appeared.It is suspected that the handpiece shorted the siu or ups.The procedure was completed, with a significant delay, using manual instrumentation.No further complication was reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h10: the navio handpiece, pfsr110137, sn(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 attempted.The reported problem was confirmed.The system will not recognize the handpiece.Upon further investigation, the handpiece connector has a damaged pin that is laying across multiple pins and will not allow the handpiece to properly connect to the system.An image was provided.The image provided confirmed the 4000000000 error code appeared.The most likely cause of this event is a damaged pin in the handpiece connector.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.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.Refer to the navio surgical system user¿s manual, section assembling the hardware, assembling the handpiece for proper set up and handling.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 uk, it was reported that during set up for a navio tka surgery, the unit displayed error messages for the handpiece.The procedure was completed, with a significant delay, using manual instrumentation.No further complication was reported.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.Internal complaint reference number: (b)(4).

• 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: 15073496
• Report Number: 3010266064-2022-00529
• Device Sequence Number: 5541492
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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?: No
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NPFS02000 NAVIO SURGICAL SYSTEM US; PFSR120031 NAVIO BBT FOOTPEDAL
• Patient Sex: Unknown