Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/18/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4) report source: (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 - 2019 - 01469.
|
|
Event Description
|
It was reported that debris was found in sterile packaging during incoming inspection of product.No patient harm.Attempts were made to obtain additional information; however, none was available.
|
|
Manufacturer Narrative
|
Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned products identified debris in the sterile packaging.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the products when they left zimmer biomet was non-conforming.The root cause of the reported event is the operator not following instructions during the manufacturing process.A corrective action has been initiated to address the 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.Unique identifier (udi) #: (b)(4).
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|