Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 (b)(6) 2022, the locking screw in question was being put into an olecranon plate, and the screw would not tighten into the va locking hole.It stripped out.The screw was vital, so the procedure was continued using another screw and plate with no delay.There was no adverse patient outcome, no further information is available.This report is for a 2.7mm/3.5mm va-lcp proximal olecranon pl 2h/lt/73mm.This is report 1 of 2 for (b)(4).
|