SMITH & NEPHEW, INC. BURR,5.5 ABRADER,180 LG, HIGH VIS, DSPL.; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72203127 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2013 |
Event Type
malfunction
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Manufacturer Narrative
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One burr, 5.5 abrader,1 80 lg, high vis, dspl was returned for evaluation of the reported complaint mode, ¿excessive shedding¿.The device was inspected dimensionally and found to meet design requirements.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.Visual inspection was performed and galling of the inner blade shaft was observed.Additionally the adapter body was cracked indicating excessive lateral load during rotation.A review of the device history record was performed which confirmed no inconsistencies (method code).After the evaluation the root cause could not be determined.The company will continue to analyze additional complaints as they are reported.(b)(4).
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Event Description
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During a hip arthroscopy procedure it was reported that there was excessive shedding.The surgeon used a shaver blade to remove the debris.A back up device was available to complete the case.There was a slight delay and no reported patient injuries or complications.
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Search Alerts/Recalls
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