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.
|
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.
|