Model Number 2010-01-040 |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 10/01/2020 |
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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During the broaching process of an anterior hip, the size 4 actis stem broke at the post and was lodged in the femur.After an hour of trying to remove the stem, the surgeon was finally able to remove the broken broach.Once the broach was removed he then continue on with the case and implanted all implants.Surgical delay of 5 minutes.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary examination of the returned instrument 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.
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Search Alerts/Recalls
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