Catalog Number 405883 |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Information (3190)
|
Event Date 07/10/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
|
|
Event Description
|
It was reported that during the procedure, the baseplate was impacted, the surgeon attempted to insert the central screw.The screw would not advance through the central hole in the baseplate.A different screw size was then attempted to be inserted but then was also hung up and would not go through.Surgeon then used central drill to see if original hole was issue.The screw would not advance again after using the drill.Surgeon could not insert a central screw and just placed 4 peripheral screws to complete the procedure.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.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
|