Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the patient had an avulsion fracture of epicondylus medialis humeri and underwent the surgery using with cancellous cervical spacer 3.0mm manufactured by synthes.Surgical incision and reduction was performed without any trouble, when the doctor tried to insert the guide wire in question it was reported that it was impossible to insert.The cause might be that the bone quality was good.Surgeon continued and the guide wire broke at approximately 5mm from the cortical bone.The surgeon tried to hold with pliers the front part of guide wire and pull for picking the residual guide wire from the bone, but it broke again at about 5mm from the cortical structure.Eventually full 30cm from the tip of guide wire was left in the bone.Surgeon tried to ream around the guide wire by using drill bit in manner of using with halo reamer.Nevertheless the front of cortical structure could not be drilled and the drill bit broke.Conclusively, the surgeon used the drill bit for cancellous cervical spacer 4.0mm by a different manufacturer instead of halo reamer, and was able to remove of the fragmented guide wire.An 80 minute surgical delay was reported.This is report 2 of 2 for complaint (b)(4).
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The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was performed and no complaint related issues were found.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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