Product complaint # (b)(4).Investigation summary: visual analysis of the returned sample exhibited an unk acetabular trial with a remarkable worn condition.Several scratches were identified throughout the device.The hex drive of the fixation screw was visible worn and edge rounded.Additionally, snap ring of the device was not longer engaged and screw was detached.The snap ring was not returned for examination.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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