510k: this report is for two unknown locking screws/unknown lot.Part and lot number are unknown; udi number is unknown.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 the patient underwent open reduction internal fixation of olecranon and radial head, and olecranon plate implantation on (b)(6) 2018.The 4 hole 2.7/3.5 va olecranon plate was implanted and the two locking screws holes were left empty.During the procedure two of the locking holes in the plate did not allow the (2) unknown locking screws to engage and would not lockdown into the plate, and with pressure used to try and insert the screw, the holes began to strip the threads of the screw.It was noted that unknown cortex screw and unknown locking screw were used to attached the plate.There was a five (5) minute surgical delay reported.The procedure was successfully completed.Patient outcome was unknown.Concomitant device reported: cortex screw (part 202.Xxx, lot unknown, quantity unknown); locking screw (part 02.211.Xxx, lot unknown, quantity unknown) this report is for two unknown locking screws.This is report 2 of 3 for (b)(4).
|