Catalog Number 257650002 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(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 tray was pulled off the shelf in the warehouse, the products were noticed to be cracked.These were not used at a hospital.Upon further evaluation of the instrument the bracket holders are delminating, peeling of the coating.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned tray base 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, a follow-up medwatch will be filed as appropriate. .
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Manufacturer Narrative
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Investigation summary: examination of the returned tray base 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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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