Catalog Number 297500635 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 09/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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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It was reported that the assembly pull rod was mis-threaded.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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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Product complaint #: (b)(4).Investigation summary: 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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Event Description
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Complaint description: it was reported that the assembly pull rod was mis-threaded./ | investigation method: checked display of return screen on (b)(4), not received./ | investigation summary:.
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Search Alerts/Recalls
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