Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Part 04.013.752s, lot 64p8672: manufacturing location: monument.Manufacturing date: august 06, 2020.Expiration date: june 30, 2029.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported that on (b)(6) 2021, patient underwent a procedure.The surgeon decided to use a retro/antegrade femoral nail (rafn) for a proximal third femur fracture.While inserting the nail, the surgeon noticed a more proximal fracture extending around the lesser trochanter region.It¿s unclear if this fracture existed before the surgery.The surgeon ultimately decided to drive the nail in further proximal and used the lateral to medial locking screw options proximally along with one a top screw.The procedure was successfully completed without surgical delay.No patient consequences noted.This report is for a rafn.This is report 1 of 1 for (b)(4).
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