Model Number N/A |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Foreign: event occurred in (b)(6).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.Product not returned.
|
|
Event Description
|
It was reported that scratch was found on the sterile package.No patient involvement.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h4; h6 complaint sample was returned and evaluated against the reported event.Visual evaluation of the returned product identified that there is a scratch on the outer sterile packaging.Dhr was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet if found to be conforming.The root cause is attributed to transit damage.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|