Catalog Number 314.742 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/22/2022 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2022, the end of the l360 drive shaft and the legs of the 12 mm ria milling cutter are split.Particles remaining in the channel.This report involves one drive shaft-minimum 360mm length-for use with ria.This is report 1 of 2 for (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.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 noted the procedure was completed successfully with a thirty (30) minute delay.The patient status/outcome was reported as stable.
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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.Device was used for treatment, not diagnosis.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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A fragment was retained in the patient.
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Search Alerts/Recalls
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