510k: this report is for an unknown reamer-irrigator-aspirator system (ria)/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 [(b)(4)].
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This report is being filed after the review of the following journal article: zollera, sd.Et al (2017), staged reconstruction of diaphyseal fractures with segmental defects: surgical and patient-reported outcomes, injury-international journal of the care of the injured, vol.48(10) pages 2248-2252 (united states of america).This retrospective study aims to illustrate the clinical and patient-reported outcomes of a two-stage long bone reconstruction procedure in order to guide surgeons and patients¿ expectations.Between 2010 and 2015, a total of 9 patients (8 male and 1 female) with a mean age of 36.1 years (range, 22-53 years) underwent initial placement of an antibiotic impregnated cement spacer followed by bone grafting.Attention is then turned to the ipsilateral femur for acquisition of reamed intramedullary aspirate (ria) bone graft (depuy synthes, west chester, pa) average clinical follow-up was 18.3 months (range, 7-33 months).The following complications were reported as follows: a (b)(6) male who had open distal tibia fracture with vascular injury had infection.This is report 4 of 4 for (b)(4).This report is for an unknown synthes reamer-irrigator-aspirator system (ria).
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