Model Number 2440-00-510 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/15/2020 |
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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It was reported that the pinnacle liner trials have the plastic tip area broken off in the dome where the screw attaches.The drill guide has a burr inside where the bit runs through.The depth gauge and screw forceps are both bent and can¿t be fixed.The reamer handle won¿t pull back to allow insertion of the grater.None of these items were used in a case they were found in the sets this way.No surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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Search Alerts/Recalls
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