Catalog Number 254400509 |
Device Problems
Break (1069); Component Missing (2306)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/23/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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A piece of the attune sizer broke off on the back table.Upon product return, it was confirmed that the spring was missing.
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Manufacturer Narrative
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The complaint states a piece of the attune sizer broke off on the back table.The investigation confirmed the failure mode as reported.The damage is consistent with the device being dropped onto the front left-hand side of the product.Whilst drop tests were conducted on the device during development, failure was recorded after multiple deliberate drops on this specific location.Suggesting appropriate care has not been taken in handling this device.The complaint shall be closed with a justified conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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