Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4) unknown lot number.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an event in (b)(6) as follows: it was reported that a surgery for upper arm proximal fracture was performed on (b)(6) 2016.The patient had two parts of surgical neck fractured.Although the patient was small, the surgeon determined to use a multiloc screw.He fixed temporarily as he detained two drill bits.He then inserted the multiloc screw in the proximal d-hole but the screw was off the target area.He also checked the distal, and the drills were also off the targeted area.The surgery was prolonged about 20 minutes.No information about patient condition and outcome available.This complaint involves 2 parts.Concomitant reported part: 1x multiloc proximal humeral nail (part 04.016.035s lot unknown).This report is 2 of 2 for (b)(4).
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