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.Procode: hrs.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.
|
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent the spectroscopic fracture surgery for distal commissural fracture of the humerus with the products in question.Screw insertion was performed after drilling with a funnel-shaped sleeve in a va 2.7 hole, but did not lock.That screw in question was removed and another hole was used to fix the plate in question.The surgery was completed successfully without any surgical delay.The screw that removed had scratches on it.Inserting the removed screw into the plate sample locked it without any problem.It is inferred that the locking mechanism of the hole failed due to the gripping when the funnel-shaped sleeve was installed.This report is for a 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 32mm.This is report 2 of 2 for (b)(4).
|