Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
|
Patient Problem
No Information (3190)
|
Event Date 09/18/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
|
|
Event Description
|
It was reported the inner sterile dust bag packaging was not sealed properly.No further information is available at this time.
|
|
Manufacturer Narrative
|
(b)(4).Complaint device were evaluated and the reported event was confirmed.Evaluation of returned device found the supplier sealing were opened for 18 products on 35 products returned.The manufacturer sealing were intact.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to supplier packaging issue.Corrective action has been initiated to address reported issue.If any further information is found which would change or alter any conclusions of information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|