Catalog Number A12MA02500812 |
Device Problems
Break (1069); Material Discolored (1170); Fracture (1260); Compatibility Problem (2960); Packaging Problem (3007)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.This report is for the first file.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event a customer reported that two k-files did not exhibit the characteristics of our product because they fractured, are irregular sizes, have faded color plastic handle, and had a different label with our identification.Additional information has been requested, but is not yet available.
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Manufacturer Narrative
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After analysis, the returned file does not meet maillefer quality standards and is obviously counterfeit.Moreover, the batch number has no corresponding with the reference (b)(4) in our system.The container and its labelling are equally recognized as fakes.
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Search Alerts/Recalls
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