(b)(6).One shelf carton of (qty 6) 72200729 dyonics 5.5mm elite stonecutter burr devices used for treatment, was returned for evaluation.The complaint states: ¿the device was noisy during use.¿ the product showed symptoms of excess heat generated.There were blue particles on the washer.The adapter body shoulder had begun to break down, shed and become distorted at the collar from excess heat generated.This did not occur with a newly opened burr.Product was tested and performed as expected.There were no unusual observations.The blade connected, ran in forward, reverse and oscillating.It switched between modes with no issue.There were no error messages indicated on the control panel.Noisy, grinding and overheating, melted material condition has been found to be consistent with devices being tested/run without or with inadequate suction/irrigation.Suction is controlled by the pump settings.The larger burr requires adequate irrigation to properly excise materials and keep cool.Per ifu: ¿ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials.¿ binding, shavings and seizing may occur due to bone/tissue plastic or metal shavings/fragments not excising efficiently.These are not to be tested without irrigation and suction.No root cause related to the manufacturing of the device was established.Product met specifications upon release to distribution.
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