Model Number 96-1673 |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 09/21/2020 |
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 product d961673 is worn and needs to be replaced, the black end that goes over the implant to tighten was slipping when the surgeon was putting implants together.Product d217863109 and d217863111 are not holding stem trials well due to the wear at the connection site.Needs to be replaced.No surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the hex connection feature is stripped.The investigation findings did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.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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