Product complaint #(b)(4).If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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.
|
It was reported that while attempting to insert a 3.5 va locking screw into a va locking hole, the screw would not lock into the plate.A 3.5 cortex screw was placed in the hole and the surgery was completed successfully without any surgical delay.Additionally, it was reported that a periarticular reduction forceps was difficult to open.However, it opened freely once it was wet with irrigation.It was believed to have bioburden.The forceps remained stiff postoperatively after washing.This report is for the plate.This is report 2 of 2 for complaint (b)(4).
|