Catalog Number 254401017 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Investigation summary: no device associated with this report was received for examination.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 will be filed as appropriate.
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Event Description
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Navigated tkr: (b)(6), (b)(6) hospital, (b)(6) 2018.Handle broken during tibial impaction.Spring and button fell off.All parts accounted for.No ae to patient.No delay to procedure.Male patient initials: (b)(6).
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: the reported event has been evaluated and will be monitored.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, will be filed as appropriate.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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 will be filed as appropriate.
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Search Alerts/Recalls
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