(b)(4).(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0009617840 - 2021 - 00009, 0009617840 - 2021 - 00010, 0009617840 - 2021 - 00011, 0009617840 - 2021 - 00012, 0009617840 - 2021 - 00013, 0009617840 - 2021 - 00014, 0009617840 - 2021 - 00015, 0009617840 - 2021 - 00016, 0009617840 - 2021 - 00017, 0009617840 - 2021 - 00019, 0009617840 - 2021 - 00020.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.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 being returned.
|
Upon reassessment of the reported event, it was determined to be not reportable.Through evaluation of the pictures provided, and comparison with the packaging drawing for the subject product, the reported complaint is unconfirmed.Per the packaging drawing, the foil pouch is folded, not sealed, and does not provide any sterile barrier.There is no non-conformance per the images provided.
|