Catalog Number 281017000 |
Device Problems
Material Deformation (2976); Scratched Material (3020)
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Patient Problem
No Information (3190)
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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 upon post-surgical examination, the small anterior glenoid neck retractor was found to be damaged and gouged on the underside near the v tip.This has created a rough surface that could be damaging to the patient.
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Manufacturer Narrative
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Examination of the returned device confirmed the reported damage.Depuy considers the investigation closed.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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