Model Number N/A |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Information (3190)
|
Event Date 04/05/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Report source: (b)(6).Customer has indicated that the product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the surgeon found that the liner had substances like burrs (like string), when the surgeon opened the sterilization package.This surgery was finished with backup product causing a 31-60 min delay.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Device with packaging was submitted for further analysis.Analysis determined that the debris material matched the bipolar liner.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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
|