Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).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.Expected, not yet received.
|
|
Event Description
|
It was reported that during incoming inspection at the warehouse, it was reported that incoming inspection member at the warehouse found a part of the sterile seal packaging is peeling off.There was no patient involvement.
|
|
Manufacturer Narrative
|
Complaint sample was evaluated and the reported event was not confirmed; review of product found the seal width to be within specification.Dhr was reviewed and no discrepancies were found.The investigation indicated that the device met specification.This event is no longer being considered an mdr reportable event as the investigation found that the device met specification, changing the initial assessment.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 additional information was received.
|
|
Search Alerts/Recalls
|