|
Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source foreign: japan.Concomitant medical products: dist tib antlat r nrw 12h ste cat#856202012 lot#475930 ; qty: 3 total, lock dist tib med lt 9h ste cat# 856211009 lot# 762010 qty: 3 total.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02519, 0001825034 - 2022 - 02520, 0001825034 - 2022 - 02522, 0001825034 - 2022 - 02523, 0001825034 - 2022 - 02524.
|
|
Event Description
|
It was reported during an incoming inspection that the sterile package was not vacuum sealed.Additional information on the reported event is unavailable at this time.
|
|
Event Description
|
No further event information is available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.No product failure was found as the products are within specifications.No further investigation or action is required after review.This complaint cannot be confirmed as the product was found to be conforming.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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
|
|
|