Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/28/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(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.
|
|
Event Description
|
It was reported that the pin broke off in driver.No additional information is available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The device was manufactured on may 27, 2010 and has therefore been in the field for approximately ten years and four months.It is unknown for how many times the device is being used.Root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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
|