Model Number N/A |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Information (3190)
|
Event Date 05/08/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).(udi #): (b)(4).Report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported during initial operating room setup, the nurse handling the femoral provisional had black residue on her gloves.There was noticed to be black debris on the inside of the left and right femoral provisional.There were five sets examined and all five sets had the same black debris.As a result of the event, a delay in procedure occurred approximately 35 minutes long.No additional patient consequences were reported.
|
|
Manufacturer Narrative
|
The reported event could not be confirmed as the product was not returned.No visual and dimensional evaluations could not be performed.Dhr (device history records) could not be reviewed, as lot number was not provided.Complaint history review determined that no further action(s) is/are required.This instrument was listed by the complainant as having experienced the same issue as other instruments returned.However, the complainant could not confirm if this part experienced the black residue issue for sure.Also, the product was not returned.Therefore, the complaint cannot be confirmed and the root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Manufacturer Narrative
|
If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|