Catalog Number 217863104 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Information (3190)
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Event Date 10/17/2016 |
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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The stem of the reamer will not engage with reamer adapter, there looks to be slight damage to the tip of the reamer.
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Manufacturer Narrative
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The device associated with this reported event was not returned for examination.A complaint database search against the provided product code did not identify and trend of reamer tip damage.The investigation could not identify or verify a root cause about the current reported event without the device to examine.Based on the inability to determine a root cause, the need for corrective action was not indicated.Monitor through (b)(4).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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