SYNTHES GMBH TFNA FEM NAIL Ø10 LE 130° L235 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.037.045S |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.
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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that on an unknown date, the patient underwent the surgery for trochanteric fracture of femur with the middle nail 10mm in question.During the surgery, the surgeon used a hammer to insert the nails because of slight difficulty of insertion.At that time, a subtrochanteric fracture of the femur was occurred.Therefore, the surgeon changed the size of the nail from middle to long.The surgery was completed successfully using tfna long nail without any surgical delay.The surgeon commented that there was no defect of the product itself because the surgeon inserted the nail by hitting with a hammer unreasonably as the cause.No further information is available.This complaint involves one (1) device tfna fem nail ø10 le 130° l235 timo15.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.Investigation summary: 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.
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Search Alerts/Recalls
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