Catalog Number 07.01702.013 |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/12/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that two virage screws broke at the weld and three others cracked at the weld intra-operatively.On one screw, the surgeon pushed on it from above after the closure top was tightened and the lower housing broke into two pieces at the welds.Then the surgeon noticed the other four screws that either broke or cracked.All of the screws were removed and replaced to complete the procedure.There were no reported patient impacts.This is report four of five for this event.
|
|
Manufacturer Narrative
|
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2022-00220 through 3012447612-2022-00224.
|
|
Manufacturer Narrative
|
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the piece from lot aax was confirmed to have a cracked weld on one side.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excess force applied while torqueing the set screws.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.
|
|
Event Description
|
It was reported that two virage screws broke at the weld and three others cracked at the weld intra-operatively.On one screw, the surgeon pushed on it from above after the closure top was tightened and the lower housing broke into two pieces at the welds.Then the surgeon noticed the other four screws that either broke or cracked.All of the screws were removed and replaced to complete the procedure.There were no reported patient impacts.This is report four of five for this event.
|
|
Search Alerts/Recalls
|