Catalog Number 121735500 |
Device Problem
Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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 packaging for the screw did not open correctly compromising sterility.No surgical delay.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary examination of the returned packed product finds it only partially opened.There is no obvious issue with the seal of the pouch.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned packed product finds it only partially opened.There is no obvious issue with the seal of the pouch.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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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