(b)(4).(b)(6).The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.Patient code (b)(4) was utilized for additional medical intervention needed to remove the reported screw.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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Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during a planned hardware explant surgery on february 15, 2017 to remove a multiloc proximal humeral nail (right) and associated multiloc screws, the surgeon didn¿t realize that he didn¿t extract all of the screws until he attempted to remove the nail.It appeared that the shape of the screw or nail was distorted.The surgeon then realized that one (1) multiloc screw was still implanted.Although the surgeon tried to extract the screw, the attempt didn¿t work.The surgeon then used an unknown carbide drill and an unknown airtome diamond bar in order to drill the nail body.The surgeon was then able to extract the screw and nail.Metal fragments (debris) were generated and remain in the patient.The surgery was successfully completed however it was delayed 90 minutes due to the reported event.The patient¿s postoperative status was noted as good.The date of initial implant is unknown.Concomitant device: 1x 04.016.034s / 5937217 (multiloc phn ø8 r cann l160 tan), 1x unk carbide drill , 1x airtome.This report is 1 of 1 for (b)(4).
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