Catalog Number 00597909529 |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/14/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).The complaint device has not been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.Discarded.
|
|
Event Description
|
It was reported during a knee procedure, the patella reaming blade would not assemble with the reamer blade.Ultimately, a new blade was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information 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
|