Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The surgical delay of four hours, the complaint indicated that the procedure was not successfully completed.This report is for an unknown reamer/unknown lot.Part and lot number are unknown; udi number is unknown.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent an unknown procedure using an expert a2fn cannulated nail.During the operation, the surgeon used an unknown old reamer set to ream with an 11.5mm diameter, however, the nail was difficult to insert into the femoral bone and had to withdraw it and replaced with a new reamer set.Unfortunately, the proximal part of the nail that connected to the jig has been bent during insertion and decided to withdraw the procedure that led to an inaccuracy of an unknown drill bit to pass through the proximal hole.Thus, the surgeon had to change with another nail to complete the procedure.The procedure was successfully completed with four (4) hours surgical delay and the patient had to undergo prolonged anesthesia.There was no patient harm reported.Concomitant devices reported: unknown drill bit (part# unknown, lot# unknown, quantity 1); unknown reamer set (part# unknown, lot# unknown, quantity 1); unknown jig (part# unknown, lot# unknown, quantity 1).This complaint involves four (4) device.This report is 4 of 5 for (b)(4).
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