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.D9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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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It was reported that trephine broke off inside the patient.The surgeon was removing screws from the patient, who already had hardware.In the process, the trephine and screw broke, leaving a piece inside the patient's femur.The patient was not stable enough to continue with the removal.The issue was observed during surgery.There were no reports of injuries, medical intervention, or prolonged hospitalization.It was reported that there was no further information regarding the issue.This report is for one (1) trephine attachment 5.5mm diameter this is report 1 of 2 for complaint (b)(4).
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