Additional product code hrs, hwc.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.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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It was reported that on (b)(6) 2020, the patient underwent a revision procedure to remove the broken variable angle locking compression plate (va-lcp) curved condylar plate and two (2) of the 4.5 mm cortex screws on femur.The patient experienced pain, nonunion and delayed healing.Originally, the patient had an initial surgery last (b)(6) 2018 where the reported devices were implanted.During the revision procedure, all the original implants were successfully removed including the generated fragments from the broken devices.Fragments were removed easily without additional intervention.The patient was revised to a retrograde/ antegrade femoral nail (rafn).The procedure was successfully completed without surgical delay.Patient status was good.Concomitant devices reported: unknown va locking screws, (part # unknown, lot # unknown, quantity 4), unknown va cannulated locking screws, (part # unknown, lot # unknown, quantity 4), unknown cortex screw (part # unknown, lot # unknown, quantity 1).This is report 01 of 03 of (b)(4).
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