It was reported that during surgery, the poly would not stay locked in the tibial base.Delay of less than 30 minutes, no injury reported.No backup device available, procedure was concluded with a poly one bigger size.
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The associated complaint packaging boxes were returned and evaluated.A visual inspection of the returned opened outer box showed no obvious signs of damage.The two inserts appeared discolored and damaged.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were within specification.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.
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