Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/28/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).G2: foreign: spain.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 that outside of a surgery, it was detected that the product has broken through the packaging.There is no additional information available at the time of this report.
|
|
Event Description
|
There is no update to the prior event description provided.
|
|
Manufacturer Narrative
|
Visual evaluation of the provided photo and move clip found the carton exhibits damage that is visually consistent with the stem puncturing through the inner sterile packaging and carton.Sterility has been breached.This complaint has been confirmed by evaluation of the provided photo and movie clip.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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
|