Additional device product code: dzj.(b)(4).Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 synthes europe reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, patient underwent initial procedure.During the procedure, as the doctor finished drilling and tried to take the drill bit out, the drill bit broke.Fragments were generated but could not be located.Broken fragments remained in the patient.An x-ray taken confirmed that the broken fragment is inside the drilled hole in the mandibule.The doctor tried to fix the screw at the hole but it could not be screwed in completely and the plate was not fixed properly.No further action was performed since the site was located very posteriorly deep inside the mouth.There was a 30 minutes surgical delay.Patient outcome was reported as stable.No clinical findings were reported.Revision procedure is not planned.Concomitant medical products: screw (part# unknown, lot# unknown, quantity 1); plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) drill bit.This is report 1 of 1 for (b)(4).
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