Visual inspection of the returned instrument found it had fractured and separated at the 60mm depth grove indicator.Both sections of the device have been returned.The patient did not retain a foreign body.A previous investigation for this type of event found the design of flute depth and geometry, as well as epoxy groove geometry was inappropriate for this application.Contributing factors include surgical technique and misuse, patient bone quality, improper measurement technique of the flutes.An update of the dimensions and material of the arsenal taps and has been implemented to reduce this type of event.Additionally, further investigation on improving inspection methods in collaboration with vendor has identified potential for significant improvement in inspection method.Current accepted inspection process is in place.
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