Model Number N/A |
Device Problems
Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/06/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source: 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.
|
|
Event Description
|
It was reported that the incoming inspection team member found debris in the sterile package.No patient involvement.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified that there is a stain on the sterile package outside the seal.The complaint has been confirmed by visual evaluation.Device history record was reviewed and no discrepancies were found.The product was likely non-conforming when it left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.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
|