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Catalog Number 04.503.226.01 |
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 09/23/2023 |
Event Type
malfunction
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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: b3: date of event is an unknown date in 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a synthes employee.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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Event Description
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It w0as reported that during a fracture procedure on an unknown date, a screw broke while being inserted.The surgeon took out part of screw and part was left in the bone.This report is for a ti matrixmidface screw self-drilling 6mm.This is report 1 of 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.A1, a2, a3: patient information added.B3: event date added.B5: event description updated.E1, e3: initial reporter and facility updated; initial reporter is a physician.H6: additional health effect impact 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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There was a slight delay as a longer plate had to be used to span the screw fragment that was left in patient.The surgery was completed successfully.
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Search Alerts/Recalls
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