Catalog Number 297500635 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 08/04/2017 |
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.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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Event Description
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It was reported that the after tightening the reclaim proximal body to the distal stem.The pull rod assembly became jammed and unable to move.It was also reported that when it got loose the pull rod assemble broke.
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Manufacturer Narrative
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Examination of the returned instrument confirmed the complaint.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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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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Search Alerts/Recalls
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