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

Model Number	PFSR120010
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during femur cutting in a navio ukr procedure, the handpiece tracker array (case-(b)(4)) was loose from the handpiece (case-(b)(4)); thus, posterior femoral condyle was cut extra 3mm.The bone defect was filled with bone cement.There was a delay fewer than 30 minutes.No other complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the navio handpiece tracker array pn (b)(6), use in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirm, factors that may have contributed to the reported symptom may have been associated with mishandling.Per the navio surgical system user's manual ¿if, at any point during the procedure, you observe that the handpiece tracker array has become loose do not execute bone removal, tighten the tracker array to the handpiece and recalibrate the handpiece¿.This failure is an identified failure mode within the risk assessment.Per complaint details, there was a delay fewer than 30 minutes.No other complications were reported.No operative reports are available.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO HANDPIECE TRACKER ARRAY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441 ; UK 55441
• MDR Report Key: 11684710
• Report Number: 3010266064-2021-00288
• Device Sequence Number: 16897912
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: PFSR120010
• Device Catalogue Number: PFSR120010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention