Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/17/2020 |
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.Foreign report source: (b)(6).
|
|
Event Description
|
It was reported that debris was found in the sterile packaging during incoming inspection in the warehouse.No patient involvement.Attempts have been made and no further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures and returned product still in packaging.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.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.
|
|
Search Alerts/Recalls
|