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

Model Number	PFSR110006
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a navio ukr procedure, when the surgeon went to bur, the bur would not spin or come out of the guard: the anspach drill was locked in.They opened the handpiece clamshell and checked the gears were moving freely, unseated the long attachment and the bur, reseated them and went back to recalibrate, but the handpiece would not home.It is unknown whether which device caused the problem.The surgery was changed to manual procedure with a delay of fewer than 30 minutes.No other complication were reported.
Additional Manufacturer Narrative
The navio long attachment, part number pfsr110006, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The evaluation followed a long attachment performance verification document.The long attachment was able to be inserted/removed without issue.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper method of inserting burr into handpiece.The surgical technique guide provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿.Per the clinical evaluation, the surgeon was reportedly satisfied with the surgical outcome, no additional interventions were required, and no patient harm resulted.It was communicated that the patient is currently healthy; therefore, patient impact beyond the reported use of the manual instrumentation to conclude the procedure would not be anticipated as per the complaint and field report, no patient injury resulted from the conventional procedure or the 0-30-minute surgical delay and the patient is ¿healthy¿.No further medical assessment is warranted at this time.This failure is an identified failure mode within the risk assessment released during the timeframe of the incident.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.

• Brand Name: NAVIO LONG ATTACHMENT
• 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: 11113801
• Report Number: 3010266064-2021-00010
• Device Sequence Number: 3595553
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/06/2021

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: PFSR110006
• Device Catalogue Number: PFSR110006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 11/07/2021
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAVIO SURGICAL SYSTEM US/SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown