Model Number N/A |
Device Problem
Component Missing (2306)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/12/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the device was missing from the packaging upon receipt.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
(b)(4).Reported event was confirmed by review of provided photograph.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event can be attributed to transit damage.The condition of the device when it left zimmer biomet is conforming to specification.If any further information is found which would change or alter any conclusions or information, a supplemental report 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
|