Catalog Number 297500635 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 04/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4.See section d for product information received.Depuy synthes has been informed that the lot number is not available.If additional information is received, d follow-up medwatch will be filed as appropriate.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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After case the scrub tech couldn't unscrew the reclaim assembly tool pull rod.Everything worked fine in surgery.
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Manufacturer Narrative
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Examination of the returned instrument confirmed the reported observation.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.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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Search Alerts/Recalls
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