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Catalog Number 54-25442S |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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When the bone screw(2.7mm) was inserted into the screw hole of the plate (54-25442s), the scraped piece was fell.The scraped piece was removed from the patient body and the screw and plate was implanted.The surgeon want to know what foreign matter was scraped.
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Event Description
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When the bone screw(2.7mm) was inserted into the screw hole of the plate (54-25442s), the scraped piece was fell.The scraped piece was removed from the patient body and the screw and plate was implanted.The surgeon want to know what foreign matter was scraped.
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Manufacturer Narrative
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The reported event that 2.7mm xxl volar dr plate, narrow, ri was alleged of 'device stripped/twisted' could be confirmed.Based on the given information, the root cause was attributed to be user related.The failure was caused by possible to much angulation during screw insertion.The device inspection revealed the following: the returned metal swarf / shaving is surely from the implanted plat as it¿s color is gray (t102).As the color of the screws are actually golden.Too much angulation during the screw insertion created a piece of metal swarf / shaving from the plate.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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Search Alerts/Recalls
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