Model Number 2217-50-041 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284); Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/24/2020 |
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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Surgeon informed us that the cup impactor was damaged when delivered.The handle was missing a piece.
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Manufacturer Narrative
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Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d4 (lot #), d9 and h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the photo confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re\2010opened as necessary.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the photo confirmed the complaint.Depuy-synthes 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.Pe code for missing component and damaged - unspecified is being retracted since the instrument's missing piece broke off.This should only be coded as breakage.
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Search Alerts/Recalls
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