Examination of the returned handle confirmed the loose condition.However, the handle is still functional.A depuy retained broach found that the broach handle assembled/disassembled and held the broach securely during simulated impacting.Previous investigations found it is important to ensure that the alignment features on both the handle and broach are mated correctly, as proper locking will extend the life of all broach handles.If these orientation features are not aligned properly, the cam will lock incorrectly onto the broach, or that extra pressures are placed on the leaf spring component, leading to deformation of the leaf spring.After this type of deformation occurs, the handle will no longer lock as tightly onto the broach as when first distributed.With correct use, the leaf spring will only flex a few millimeters.Based on the investigation, the need for corrective action is not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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