(b)(4).Concomitant medical products: (46) 103531 ¿ ti low profile screw ¿ 860850, (8) 103533 ¿ ti low profile screw ¿ 860850.Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Dimensional analysis was conducted on three pieces of each size and confirms that the item number 103533 measures as 20mm and the item number 103531 measures as 30mm.Visual inspection was conducted on the remaining returned product and found that all returned 30mm screws measured as 20mm and all returned 20mm screws measured as 30mm.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the manufacturing process.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: 0001825034 - 2019 - 01144, 0001825034 - 2019 - 01145, 0001825034 - 2019 - 01146, 0001825034 - 2019 - 01147, 0001825034 - 2019 - 01148, 0001825034 - 2019 - 01149, 0001825034 - 2019 - 01150, 0001825034 - 2019 - 01152, 0001825034 - 2019 - 01153, 0001825034 - 2019 - 01154, 0001825034 - 2019 - 01155, 0001825034 - 2019 - 01156, 0001825034 - 2019 - 01157, 0001825034 - 2019 - 01158, 0001825034 - 2019 - 01159, 0001825034 - 2019 - 01160, 0001825034 - 2019 - 01161, 0001825034 - 2019 - 01162, 0001825034 - 2019 - 01163, 0001825034 - 2019 - 01164, 0001825034 - 2019 - 01165, 0001825034 - 2019 - 01166, 0001825034 - 2019 - 01167, 0001825034 - 2019 - 01169.
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