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.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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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Device report from japan reports an event as follows: it was reported that about 10 years ago, the patient underwent the orif surgery for trochanteric fracture of femur.The surgery was completed successfully with no surgical delay.After surgery, secondary fracture was found around the distal part of the nail.It was also confirmed that the blade penetrated the bone head and the area around the bone head collapsed, which affected the acetabulum.A revision surgery will be performed to extract the nail and the blade.After that, the surgeon will judge how to treat the secondary fracture site.No further information is available.This report is for a pfna-ii ø10 xs 125° l170 tan.This is report 1 of 2 for (b)(4).
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