Catalog Number 244000510 |
Device Problems
Break (1069); Device Reprocessing Problem (1091)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/03/2016 |
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.(b)(4).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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Handle was observed to have some kind of residue on it.Handle was sent to spd for cleaning.Residue would not come off and handle cover was dropped and broken.
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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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Examination of the returned instrument confirmed the complaint.The residue is unknown but is rubbing off by fingernail.Half the sleeve component broke off.The root cause of the fracture is too harsh of chemicals.A two-year search of the complaint database did not identify a trend for either issue for this product code.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.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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