Model Number N/A |
Device Problems
Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/18/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that during inspection of circulated products in the warehouse, the product was identified as having damaged sterile packaging.Upon initial review of the pictures provided, a hair like substance was present in the packaging.No patient involvement and no adverse consequences reported.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).Report source: foreign: (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.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product identified damage to the sterile packaging (blister).Sterility has not been compromised.Evaluation of the returned product confirmed there is white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Device history record was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the damaged packaging can be attributed to transit damage, and a packaging design issue.The root cause of the debris in sterile packaging is likely to be due to transit damage causing the foam packaging to become abraded and shed, and a packaging design issue.A corrective action was previously opened to address the reported event.This event is no longer considered reportable.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
|