Catalog Number 217863136 |
Device Problems
Difficult to Insert (1316); Material Twisted/Bent (2981); Naturally Worn (2988)
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Patient Problem
Not Applicable (3189)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.
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Event Description
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Total knee revision.Case was not explanting a depuy implant.While reaming, some of the reamers were breaking free from the hudson adapter where they were not able to fully engage the cortices.There was a five minute delay due to difficulty reaming.Flagged broken instruments and opened another set to continue surgery.Surgery was completed successfully.No patient consequences.Once processed through spd, multiple reamers (16,17,18,19,20,22) were noticed to have rounded ends where it attached to the hudson adaptor.It was also noticed that both hudson adaptors and t-handles have worn hudson adaptors.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: examination of the submitted device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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