Catalog Number 217863183 |
Device Problems
Break (1069); Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/09/2015 |
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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The connection point tends to slip, causing damaged to the modified hudson adapter and the reamer connection point.After this occurs, the adaptor causes damage to other reamers.
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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.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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Examination of the submitted device found wear and areas of deformation.The root cause is attributed to product wear out.Based on this investigation's determination of wear out as the root cause, no corrective action is being pursued.Continue to monitor via (b)(4).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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