Patient id and date of birth are not available for reporting.(b)(4).Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).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) 2017, patient underwent surgery for femur trochanteric fracture.During the procedure, the surgeon applied tfna (tfn-advanced proximal femoral nailing system).It was reported that the surgeon inserted reamer in medullary cavity without using the reaming rod.The reamer head came off and was left inside of the medullary cavity.Patient outcome was reported as well.Procedure was successfully completed.No fragments were generated from broken device.There was a surgical prolongation of five (5) minutes reported.Concomitant devices: reaming rod (quantity 1).Tfna implants (quantity 1).This report is for one (1) 13.0 mm medullary reamer head.This is report 1 of 1 for (b)(4).
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