Additional narrative: without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Patient code (b)(4) used to capture additional medical/surgical intervention required.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 (b)(6) reports an event as follows: it was reported on an unknown date that on (b)(6) 2020, the patient will undergo the revision surgery with screws and nesplon cables due to the bone quality or surgical technique issues.Previously, it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for proximal femoral fracture around the stem with the cable in question.During the surgery, the surgeon applied the 50kg tension to the cable while confirming with the surgical elevator.The surgery was completed successfully without any surgical delay.Next date to the surgery, the patient had difficulty in standing up due to the pain.2-weeks after the surgery, the surgeon confirmed that the cable part bone was torn apart and schedule for revision surgery on (b)(6) 2020.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.Concomitant product reported: unk - plates: 4.5 mm lcp proximal femur plate (product# unknown, lot# unknown, qty 1) unknown cerclage positioning pin (product# unknown, lot# unknown, qty unknown).This complaint involves one (1) device.This report is for (1) 1.7mm cocr cable with ti crimp 750mm-sterile.This report is 1 of 1 for pc (b)(4).
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