(b)(4).Report source: foreign: country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual review for disposable with spatula mixing bowl [item: 00504901100, lot: 65458625] confirms (1) pouch with one piece of loose blue debris.Debris exceeds.60 sq.Mm.Visual review for disposable with spatula mixing bowl [item: 00504901100, lot: 65459017] confirms a total of (7) pouches with debris.(4) pouches have one piece of loose blue debris exceeding.60 sq.Mm.(1) pouch has three pieces of loose blue debris of those two pieces exceed and one piece is less than.60 sq.Mm.(1) pouch has four pieces of loose blue debris all exceeding.60 sq.Mm.(1) pouch has one piece of loose dark debris exceeding.60 sq.Mm.Device history record (dhr) was reviewed and no discrepancies were found.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The likely condition of the product when it left zimmer biomet was non-conforming.The root cause of the reported event is the operator not following the work instructions provided.A corrective action has been previously initiated for the reported event.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.Multiple mdr reports were filed for this event, please see associated reports: 0001526350 - 2022 - 01056, 0001526350 - 2022 - 01057, 0001526350 - 2022 - 01058, 0001526350 - 2022 - 01059, 0001526350 - 2022 - 01060, 0001526350 - 2022 - 01061, 0001526350 - 2022 - 01062.
|