Catalog Number 6260-4-090 |
Device Problems
Fracture (1260); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/12/2015 |
Event Type
malfunction
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Event Description
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Revision of competitor (biomet) product.During the revision, the extractor cross threaded.No delay or adverse consequence to patient.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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The event regarding the extractor cross threading was confirmed.Visual inspection confirmed the reported event - the threads fractured.A material analysis was not performed, as thread damage/fracture is a known failure.The fracture surface is consistent with an overload condition.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.The event was confirmed but no material or manufacturing defects were observed on the device features examined.Product surveillance will continue to monitor for trends.
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Event Description
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Revision of competitor (biomet) product.During the revision, the extractor cross threaded.No delay or adverse consequence to patient.
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Search Alerts/Recalls
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