Device Problem
Device Operates Differently Than Expected (2913)
Patient Problem
Device Embedded In Tissue or Plaque (3165)
Event Date 11/30/2010
Event Type
malfunction
Manufacturer Narrative
(b)(4).Their request is for all device / patient complaints to have a mdr completed.According to safewire procedures this complaint didn't warrant a mdr to be completed as it didn't impact the patient by surgical intervention, death or serious injury.
Event Description
Pedicle screw case - upon conclusion of the procedure it was found that the end of the ywire had broken off.This device part of lot 292-10 item 145ba22-4.The broken piece of ywire was no more then 5mm in length and no evasive procedure took place took place to remove the broken wire.