Catalog Number 254500504 |
Device Problems
Break (1069); Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2017 |
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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Attune impactor handle, cat no.D254401017,lot no.Nw152969 broke during tibia preparation and attune artic surface ring(cat no.-d254500504,lot no.Mvmbsy780) came out while removing insert during attune case at (b)(6) causing a surgery delay of 5 mins to find broken parts, this has happened the fourth time.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary the reported device was not returned for evaluation, however review of the provided photograph confirms the reported event.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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