Catalog Number 51-104110 |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/23/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported while reviewing items at the distributorship, the inner sterile pouch was found to be damaged.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
Upon reassessment of the reported event, the device was determined to be not reportable as there was no breach in sterility.The initial report was forwarded in error and should be voided.
|
|
Event Description
|
Upon reassessment of the reported event, the device was determined to be not reportable as there was no breach in sterility.The initial report was forwarded in error and should be voided.
|
|
Search Alerts/Recalls
|