Catalog Number 2000-1005 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/25/2021 |
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 3012447612-2021-00463 through 3012447612-2021-00467.
|
|
Event Description
|
It was reported five polaris plugs stripped intraoperatively.They were removed and replaced without patient impacts.This is report two of five for this event.
|
|
Manufacturer Narrative
|
Device evaluation: the returned devices match the information in the complaint file and were examined.There were five returned closure tops, however one was lost in the wash process (lot j6427145) and is unable to be inspected.The four that were able to be inspected revealed stripped hex on three (lot numbers j6364237, j6392969 and j6435242) and one with damaged threads (lot j6364237).Potential cause: root cause was unable to be determined.This event could possibly be attributed to applying off-axis forces during insertion.Dhr review: per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
|
|
Event Description
|
It was reported five polaris plugs stripped intraoperatively.They were removed and replaced without patient impacts.This is report two of five for this event.
|
|
Search Alerts/Recalls
|