Model Number N/A |
Device Problem
Component Missing (2306)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/06/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).0001822565 - 2018 - 04106 ; 0001822565 - 2018 - 04107; 0001822565 - 2018 - 04105; 0001822565 - 2018 - 04109; 0001822565 - 2018 - 04110; 0001822565 - 2018 - 04111; 0001822565 - 2018 - 04112; 0001822565 - 2018 - 04113.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that tasp shim was worn and returned, found missing one or both ball bearings.No patient involvement was reported.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device identified signs of repeated use and has components missing.Device history record (dhr) was reviewed and no discrepancies were found.The root cause was determined to be design deficiency.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
|