No patient information provided as no patient was involved in this concern.Rma issued.Replacement tap 5.5 shipped to site (b)(4) 2014.Medtronic investigation of returned suspect device finds that, as reported, the tip of the instrument has been broken off and is blocked with bony material.Mechanical failure, pieces broken, directly caused event.
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Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.
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