Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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) 2019, the patient underwent open reduction internal fixation surgery for proximal humerus fracture and femoral subtrochanteric fracture.On an unknown date, the patient visited the hospital and reported pain on the humerus and femoral point.It was confirmed that the humerus bone head was varus, the screw head was out of the bone and the tfna blade was telescoping about 10mm.The revision surgery was completed successfully on (b)(6) 2020 to remove the screw at the humerus, the blade at femur, and insert a lag screw at femur.Concomitant device: unknown tfna nail (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) tfna helical blade 70mm sterile.This is report 1 of 2 for (b)(4).
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