(b)(4).Information asked for but unknown or not provided during initial contact.Should the information be provided later, a supplemental medwatch will be sent.The handpiece was received with the nose cone cracked.It was connected to a generator, evaluated with a test instrument and was found to be functional.The instrument was disassembled to inspect the internal components and the moisture indicator was positive and the acoustic isolator was torn.Due to the cracked nose cone, moisture entered the hand piece mid housing.It is possible that this caused the user reported malfunction of incomplete pre-run test.A possible cause of the nose cone being cracked is the sterilization method due to the heating and cooling of the sterilization cycles is a stressor.
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