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Catalog Number V040252025025 |
Device Problems
Break (1069); Entrapment of Device (1212); Material Separation (1562)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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Event Description
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It was reported that four reciproc blue files broke during use by three different dentist; all broken at approximate 16 mm length, broken parts not removed.Update the broken parts have either been incorporated in filling or outcome of filling and removal is still pending.Blister pack will be forwarded.
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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 has not been returned 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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Manufacturer Narrative
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Involved product that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhrs review (batches #1702917, #1703250, #1703364, #1703205 and #1703369).Unused reciproc blue files r25 8/100 25mm 025 were evaluated and were found in compliance with specifications.According to our prescriptions, we can consider that the production vdw batch #359748 is conforming (representative sampling).No fault was found, production meets specifications.
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Search Alerts/Recalls
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