Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 04/02/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Foreign country: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01636, 0001825034-2020-01638.
|
|
Event Description
|
It was reported that the incoming inspection team member found debris in the sterile package.No patient involvement.It was reported that no further information is available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).The event was confirmed with product received.Evaluation of the returned product confirmed the sterile packaging (blister and foam) is damaged and there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Sterility was not compromised.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 conforming to specification.The root cause of the reported event it likely to be damage during transit causing the foam packaging to become abraded and shed.The device evaluation found no malfunction and the event did not contribute to injury, event is no longer considered reportable, and initial report should be voided.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
|
Upon investigation, it has been determined that the debris in the sterile packaging did not compromise sterility.Event is no longer considered reportable, and initial report should be voided.
|
|
Search Alerts/Recalls
|