While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.During evaluation cap was off the handpiece head.Cap threads where clean and saw no signs of lock tight.Cap also had cap damage from rotor coming in contact with cap.Put cap back on and it drew up tight.During testing handpiece failed specs due to bur bearing damage.Bearing was still intact but had play/wobble.Turbine/head drive needs replaced due to old style cap.
|