Additional device product code: ktt.
(b)(4).
The device has been received, the investigation is in progress, 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.
|
It was reported that on october 22, 2020, the patient underwent removal of a proximal femoral nailing system (tfna) due to tfna fenestrated screw broke in the thread.
During the procedure the tfna nail, fenestrated screw and a distal locking screw were removed successfully without further damage and the patient was revised to a bipolar hip.
The femur split during implantation of bipolar hip and a cerclage cable was used to stabilize the femur and implant.
The procedure was successfully completed.
The patient's status is unknown.
Concomitant device reported: tfna nail (part #: 04.
037.
242, lot #: h607959, quantity: 1), unknown locking screw (part #: unknown, lot #: unknown, quantity: 1).
This report is for one (1) tfna fenestrated screw 90mm.
This is report 1 of 1 for complaint (b)(4).
|