SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE STONECUTTER BURR; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200728 |
Device Problems
Material Separation (1562); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that after connecting the burr on the handpiece, the burr stopped turning and the handpiece sets to alarm state.Removing the burr, plastics had been damaged.The surgeon changed the handpiece and the incident repeated again.Then the surgeon used another burr (other product reference with bigger diameter and it was ok.) no plastics pieces were left into the patient.A backup device was used to complete the surgery.No significant delay or patient injury reported.
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Manufacturer Narrative
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The reported stonecutter burrs intended for use in treatment, have not been returned for evaluation, however a photograph was supplied, visual assessment of the photograph confirmed the polycarbonate components the sluff chamber and adapter body are melted and fused together.The cause of the melting/seizing is due to improper fluid flow during operation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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Manufacturer Narrative
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One 4.0 mm elite stonecutter burr was returned for evaluation.Visual assessment of the burr found that the polycarbonate components the sluff chamber and adapter body are fused together showing evidence of being operated with inadequate irrigation.The cause of the melting/seizing is due to improper fluid flow during use.Per the device instructions for use under warnings ¿periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running¿.No root cause related to the manufacture of the device can be established¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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Search Alerts/Recalls
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