Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/02/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source- foreign.The event occurred in (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 packaging was compromised, allowing the cement powder to leak out.No further information is available at this time.
|
|
Manufacturer Narrative
|
(b)(4).Complaint samples was evaluated and the reported event was confirmed.Evaluation of returned products device found the supplier sealing were opened.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 or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|