Catalog Number 233225014 |
Device Problems
Fracture (1260); Difficult to Remove (1528)
|
Patient Problem
No Information (3190)
|
Event Date 03/21/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product not returned.
|
|
Event Description
|
It was reported that the screw head stripped before final seating of the implant.The screw was subsequently removed and resulted in an approximate thirty minute delay.
|
|
Manufacturer Narrative
|
Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|