Patient¿s weight is not provided for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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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It was reported that on (b)(6) 2018, the patient underwent an intramedullary (im) nail procedure.The surgeon reamed the femoral canal, finishing with a 12.5 mm reamer and inserted an 11 mm left recon nail.As the surgeon inserted the nail, it became very tight at the level of the fracture site and was not able to advance the nail any further.The nail extraction rod was attached to the driving cap and attempted to remove the nail.The surgeon was able to back the nail out slightly but not all the way.Then tried to drive the nail in again but after several strikes of the mallet on the driving cap, the driving cap broke.The threads of the driving cap broke off inside of the insertion handle so that another driving cap could not be used.Then surgeon removed the insertion handle from the nail and attached the nail extraction bolt to the nail and was able to remove the nail.After the nail was removed, the surgeon decided to go down to a 10 mm recon nail and was able to insert the nail by hitting the insertion handle with the mallet.Fragments were generated from the broken device and removed easily without additional intervention.There was a surgical delay of twenty (20) minutes related to the taking out of the originally placed nail and replacing with another.The procedure was completed successfully with the patient in stable condition.Concomitant device reported: reamer (part# unknown, lot# unknown, quantity# 1); extraction rod (part# unknown, lot# unknown, quantity# 1); mallet (part# unknown, lot# unknown, quantity# 1); insertion handle (part# 03.033.001, lot# l551431, quantity# 1).This report is for one (1) 11mm / ti cann frn.This is report 2 of 2 for complaint (b)(4).
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