SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW; SAW, POWERED, AND ACCESSORIES
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Catalog Number 7210976 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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One 7210976 disposable 4.5mm incisor plus elite blade returned.The complaint was in regards to light metal residue.Visual inspection shows have flats worn onto a few teeth.There are light contact abrasion wear bands to the inner blade¿s od surface.This observance is attributed to inadvertent side load pressure and contact with a hard surface.Per the device ifu, ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.And also ¿do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope.Damage to both instruments is likely.Damage to the blade can range from a slight distortion or dulling of the blade edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.¿ no further investigation is warranted at this time.(b)(4).
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Event Description
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It was reported that the blade left a metal residue in the patient.All residue was removed from the patient and a backup device was available to complete the procedure.
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