(b)(4).Report source: foreign: country: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02390, 0001822565 - 2020 - 02391, 0001822565 - 2020 - 02392, 0001822565 - 2020 - 02393, 0001822565 - 2020 - 02394, 0001822565 - 2020 - 02395, 0001822565 - 2020 - 02396, 0001822565 - 2020 - 02397, 0001822565 - 2020 - 02398, 0001822565 - 2020 - 02399, 0001822565 - 2020 - 02401, 0001822565 - 2020 - 02402, 0001822565 - 2020 - 02403, 0001822565 - 2020 - 02404, 0001822565 - 2020 - 02405, 0001822565 - 2020 - 02406.
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products confirmed that 18 out-of-20 contain foreign debris.Sixteen of the 20 sterile pouches contain a loose blue particle.One sterile pouch contains 2 particles.All loose particles exceed the.60 sq.Mm size allowed by zpc 8.400 rev.52, as measured with the tappi chart 25-2007-187-00-ey.One sterile pouch has a hair-like fiber measuring approximately.400 in length.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 parts when they left zimmer biomet control is considered non-conforming based on the evaluation of the returned products.The loose blue particles likely came from the excess flash generated during the molding process of the mixing bowl and/or during the trimming of this excess flash.Although a definitive source of the hair-like fiber cannot be determined, it was introduced during manufacturing because it was located in the sealed pouch.The root cause of the reported issue is attributed to a manufacturing issue.A corrective action has been initiated to address this issue.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.
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