Catalog Number 046W0AN00002 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/02/2021 |
Event Type
malfunction
|
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 3003853072-2021-00104.
|
|
Event Description
|
It was reported that threads of three blockers were damaged during surgery.They were removed and replaced with other blockers to complete the procedure without patient impacts.This is report one of three for this event.
|
|
Manufacturer Narrative
|
Device evaluation visual inspection revealed both returned plugs have thread damage.One of the plugs also has drive mechanism damage/deformation.Potential cause root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during plug insertion.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
|
|
Event Description
|
It was reported that threads of three blockers were damaged during surgery.They were removed and replaced with other blockers to complete the procedure without patient impacts.This is report one of three for this event.
|
|
Search Alerts/Recalls
|