Device Problems
Separation Failure (2547); Mechanical Jam (2983)
Patient Problem
No Code Available (3191)
Event Date 11/19/2015
Event Type
Injury
Manufacturer Narrative
(b)(6).Report is for one (1) unknown reamer head.Device is an instrument and is not implanted/explanted.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event Description
It was reported that while the surgeon was reaming, the reamer head became stuck in the medullary canal.The physician attempted to reverse the drill and the reamer shaft came apart.A ball tip reaming rod was used to remove the parts without difficulty.There was a surgical delay of five (5) minutes.The surgery was successfully completed without further incident.This report is for one (1) unknown reamer head this is report 1 of 2 for (b)(4).