(b)(4).The handpiece was received attached to a harh36 disposable device.The handpiece was forcibly removed from the disposable and the nose cone was cracked and the mount was noted to be loose.Upon visual inspection no anomalies were found with the threaded of the stud as reported in the event description.No functional testing could be performed due to the nose cone was extremely cracked and no instrument could be attached to the handpiece.However, the handpiece was connected to the generator and ¿no uses remaining - replace hand piece¿ alert screen was displayed by the generator.The instrument was disassembled to inspect internal components.The moisture indicator was positive.The transducer assembly was not held in place due to the cracked nose cone, so torquing on the disposable resulted in twisting only the handpiece transducer assembly until the internal wires got disconnected.Due to the cracked nose cone, moisture entered the hand piece mid housing.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.It is possible that the ingress of moisture affected handpiece functionality.The batch history records were reviewed with no anomalies noted during the manufacturing process.
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