|
Model Number N/A |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/12/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source: foreign: country: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01662, 0001825034-2021-01663, 0001825034-2021-01664, 0001825034-2021-01666, 0001825034-2021-01667.
|
|
Event Description
|
It was reported circulated items were investigated and identified debris in sterile packages.No patient involvement.No additional information.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; h2; h3; h4; h6.Visual evaluation of the returned product provided 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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event is likely to be due to transit damage causing the foam packaging to become abraded and shed.Upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.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
|
Upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.
|
|
Search Alerts/Recalls
|
|
|