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

Model Number PFSR110137

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/23/2021

Event Type  Injury  

Event 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.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the navio handpiece, part number: pfsr110137, serial unk and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation, or field service report.A complaint history review for similar reported/confirmed complaints has identified prior events.The navio surgical technique manual (500197) provides guidelines for implant placement and planning in the ¿performing pfa with the navio surgical system" and "performing uka with the navio surgical system" sections.Per the clinical evaluation completed on 27-apr-2021, the root cause of the tracker array loosening from the customer handpiece could not be definitively concluded, although the resulting 3mm condyle deformity was reportedly a direct result of the loosened array.The assessed patient impact was the reported 3mm posterior condyle defect (which was reportedly filled with bone cement) and the 0-30-minute surgical extension.Further impact due to use of additional cement to fill the defect could not be determined.No further medical assessment could be rendered 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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441 ; UK 55441
• MDR Report Key: 11684711
• MDR Text Key: 245986034
• Report Number: 3010266064-2021-00289
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention