Catalog Number A041702510103 |
Device Problems
Break (1069); Material Separation (1562)
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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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Event Description
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In this event it was reported that a protaper hand file separated; outcome is unknown, though there is no indication that injury resulted.
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Manufacturer Narrative
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There has been a previous report received where this malfunction with a similar device resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21 cfr part 803.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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Manufacturer Narrative
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Multiple unsuccessful attempts were made to obtain the patient outcome.The involved file is actually broken at the tip of the active part (torque + fatigue).No material defect was found during analysis of the rupture pattern.Unused product has been evaluated according to our prescriptions and was found in compliance with specifications (measures, torque test).Nothing unusual to report was found during dhr review.Root causes are not identified.This kind of event is tracked and we monitor the trend.
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Search Alerts/Recalls
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