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Catalog Number 292.120.01 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problems
Foreign Body In Patient (2687); Insufficient Information (4580)
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Event Date 01/25/2024 |
Event Type
malfunction
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Event Description
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Device report from depuy synthes reports an event in colombia as follows: it was reported that the product fractured during surgery on (b)(6) 2024.It was inside the patient.No further information is provided.This report is for one (1) 1.25mm kirschner wire w/trocar point 150mm this is report 1 of 1 for complaint (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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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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.A manufacturing record evaluation was performed for the finished device 292.120.01 lot # 68p8364, and no non-conformances were identified.Part #: 292.120.01, lot #: 68p8364, manufacturing site: balsthal, release to warehouse date: 17-sep-2020.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The procedure was completed successfully with no surgical delay.Generated fragments remain within the patient.
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Search Alerts/Recalls
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