Catalog Number A0754225G9A03 |
Device Problem
Break (1069)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, 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.
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Event Description
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In this event it was reported that a waveone gold file broke during use.The separated piece could be retrieved.Further information about potential patient's injury pending.
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Manufacturer Narrative
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Several assorted waveone gold instruments have been returned.Two waveone gold primary are in loose, the 8 other files are unused (2x w1gs, 2x w1gp, 3x w1gm and 1x w1gl).The files in loose have been analyzed.One file is actually broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture pattern.Second file has no damage and seems unused.The two unused w1gp 25mm have been evaluated and were found in compliance with specifications.Nothing unusual to report was found during dhr review (batch #1660625).Multiple unsuccessful attempts were made to obtain the patient outcome.
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Search Alerts/Recalls
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