(b)(6).Unknown date between (b)(6) 2017.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a revision of hip pinning was conducted on (b)(6) 2017 after the patient was implanted on (b)(6) 2017.The patient was revised to a 4.5mm proximal femur plate.Five 6.5mm partially (32mm) threaded cannulated screws (80, 90, 95, 100, 110mm) and four washers were removed from the patient; one washer was left in patient.Removal of hardware was quick and easy.The screws were replaced with a proximal femur plate as the screw fixation failed.The surgeon was unable to retrieve the washer implanted in the patient because she plated over the screw.Originally, she was going to leave it in, but then decided to try and take out the screw and the washer after plating.The screw was able to be retrieved, but not the washer.The procedure was completed successfully and the patient was reportedly stable.Concomitant devices: washer (part 219.99, lot unknown, quantity 5) this is report 5 of 5 for (b)(4).
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