Catalog Number 199721001 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problems
Unspecified Infection (1930); Foreign Body In Patient (2687)
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Event Date 10/26/2023 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in australia as follows: it was reported that the patient underwent revision (removal of hardware) yesterday, october 26, 2023, due to an infection and 3 broken screws insitu.Original surgery date:april 26, 2021.Hardware sent to pathology for testing.The surgeon is not concerned regarding broken hardware and is submitting a customer complaint as per protocol.This report is for one (1)5.5 exp verse unitized set scr this is report 3 of 10 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: d2b: additional product code: kwp, osh, mni,kwq and mnh d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 additional clinical and medical device codes added.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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Revision surgery was completed successfully.It was further reported broken fragments remained in the patient.No additional intervention was used to remove the fragments.Patient status is unknown.(b)(4) is linked to (b)(4) to capture additional impacted products.
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Search Alerts/Recalls
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