Model Number 2178-63-176 |
Device Problems
Material Twisted/Bent (2981); Naturally Worn (2988)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 06/18/2020 |
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 end of size 16 reamer is rounded off, due to wear would not stay connected to the adapter.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: update 10-aug-2020: the investigation was re-opened upon the receipt of the product.Examination of the returned device confirmed the reported event.The investigation attributed the root cause to normal use and servicing and did not establish that a broader investigation or corrective action was necessary.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.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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