Device report from columbia reports an event as follows: it was reported that during a procedure on (b)(4) 2023, a patient suffered friction burns from removal of titanium elastic nails (ten).The extraction clamp was in poor condition and did not properly grasp the nails, resulting in increased manipulation and macerating of the tissue.Soft tissue debridement was performed and bactigrass was placed on the burn.Patient was undergoing extraction of the tens nail due to consolidated osteosynthesis.This report is for a synream reaming rod ã¸2.5 long l1150.This is report 2 of 2 for (b)(4).
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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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.G4: device is not distributed in the united states, but is similar to device marketed in the usa.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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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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