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Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2021, the patient underwent the open reduction internal fixation (orif) surgery for the proximal humeral fracture with the instruments and nail in question.The surgeon checked the nail size to be used before surgery.The surgeon was planning to use a 9.5 mm nail, but in the preoperative image, the medullary cavity was unexpectedly small, so he used an 8.0 mm nail.The intramedullary nail was inserted through the guide rod, but the medullary cavity was too narrow to get inside.The surgeon used a hammer because the nail could not be inserted (sales advised against it.The hospital did not have a reamer).The nail could be inserted up to the specified position.The surgeon inserted three proximal screws and moved on to insert the distal screws, but the drill bit interfered with the nail, and it did not go in, so the surgeon removed the drill bit, tap it with a hammer, let it go through the intramedullary nail, re-attach it to the drill bit, and drill to the opposite side.After measuring, a screw was inserted.Because the drill bit interfered on the proximal side as well, the same procedure was used for penetration, measurement, and insertion.After insertion of the distal screws, the surgeon checked with images to see if it was in, but it was difficult to see, so the surgeon once took off the insertion handle and internally and externally rotated the patient arm, and the surgeon found out that the distal screws were dislodged from the intramedullary nail.The dislodged screws were removed, and the removed insertion handle was reattached.A pre-drill was performed using a set of sleeves and a 2.4 mm k-wire to be used as a lateral stop, and a 3.0 mm re-pre-drill was performed on the drilled hole.Finally, a 3.2 mm drill was performed to insert the screws.Both proximal and distal screws were inserted using the same method.The endcap was inserted last and closed the incision after confirmation.A final check was performed on the postoperative x-ray to confirm that there was no deviation of the screw, but it was found that the outer bone was partially split at the distal end of the nail.The surgery was completed within thirty (30) minutes surgical delay.The surgeon commented that soft tissue was thick, and the sleeve was not firmly extended until it came in contact with the bone (skin incision was too small).No further information is available.This report is for one (1) aiming arm knob f/03.019.009 f/multiloc prox humeral nail.This is report 7 of 20 for complaint (b)(4).
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