Model Number 2570-00-120 |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problem
No Code Available (3191)
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Event Date 06/23/2020 |
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 stem on size 6 summit broach was bent while trying to extract the broach from the patient.It is bent to the point that it cannot attach to the broach handle appropriately.The broach has been used in over 200 surgeries.The broach was hard to extract so the time of the surgery was extended by 30 minutes while the surgeon tried to extract the broach.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Visual exam found the taper is bent/deformed and exhibits heavy circular scratching and wear.Functional testing found broach would not properly assemble.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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