It was reported that on an unknown date, part no.319.006, this item was broken during surgery case and replacement needed.There were no reported patient consequences or delays in surgery.This report is for one (1) depth gauge for 2.0 and 2.4 screws, long.This is report 1 of 1 for (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 expected to be returned for manufacturer review/investigation but has yet to be received.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.
|