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: unknown event date e1: initial reporter is j&j company representative 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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It was reported that on an unknown date, during a revision tfna procedure, the hybrid handle was used to attach the tfna, but it was not property connected.During insertion the notch bent and the tfna nail was wasted.A new insertion handle and a bigger diameter nail was used.During reaming a 10.5 reamer head was used and broke intra-op, ria 2 was then used and then the 12.5 was used but could not snap off reamer head off shaft.There was 5 minutes surgery delayed due to the reported event.There was no patient consequences.This report is for one hybrid insertion handle for (b)(4).
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