Catalog Number 110030304 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 10/03/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2018-09938.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 the incorrect product was found in the package.There was no patient involvement.
|
|
Manufacturer Narrative
|
Report source foreign - (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.No device was received; however, photos were received which show the tamper proof tape has been broken and the carton is open.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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
|