Device report from synthes europe reports an event in (b)(6) as follows: during an expert asian femoral nail surgery, on the shaft reaming process, a reamer head detached from flexible shaft.It could not be removed and still remains in the patient with no reoperation planned.The procedure as completed with a delay of five to ten minutes.This report is for an unknown flexible shaft.This is report 2 of 2 for (b)(4).
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Year of birth reported as (b)(6); month and day unknown.This report is for an unknown flexible shaft/unknown lot.Device is an instrument and is not implanted/explanted.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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