"it was reported that during testing of a stryker core impaction drill by the customer prior to a procedure, it was noted there was a broken bur inside the handpiece.It was also reported that there was no patient involvement, adverse consequences, medical intervention or delays as a result of this event" stryker instruments conducted a complaint investigation as a result of this information (stryker reference (b)(4)).However, through the course of the investigation, it was confirmed that the broken bur was not a stryker bur.The manufacturer of the bur, ss white burs inc.Has been notified of this event on (b)(6) 2012.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
|