Catalog Number A0410225G0103 |
Device Problem
Break (1069)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received where this malfunction 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 21cfr 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.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.
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Event Description
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It has been reported that protaper gold s1 25mm ster files broken in the 1st or 2nd case a request for product return and further information has been made.
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Manufacturer Narrative
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Six protaper gold shaping files s1 25mm in loose were returned.Three of the files are not broken but untwisted at the tip of the active part (torque).No material defect was found during analysis of the damaged areas.The three other files are not damaged.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1670130).Root causes are not identified.We will track this kind of event and monitor the trend.The tool marks which were made by the practitioner show that the returned files were used several times.As reminder, multiples reuses may increase the risks of untwisting or breakage.
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Event Description
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Additional information was received indicating that the broken portion of the file was removed from the patient¿s tooth.
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Search Alerts/Recalls
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