This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The 1.5x 4mm dir-drv lact scw 2pk (part# 915-2215, lot# 700710) were returned in a red biohazard bag.The screws were removed for visual inspection.Both screws showed signs of wear on the head and had fractured in the body of the threads, near the head.Device history record (dhr) was reviewed and no discrepancies were found.There are no indications of manufacturing defects.The instructions for use (ifu for this product states in the section titled warnings: improper selection, placement, positioning, or fixation of the implant can cause a subsequent undesirable result.Devices should not be located directly under a suture site.The surgeon is to be familiar with the devices, the method of application and the surgical procedure prior to performing surgery.Investigation results concluded that the reported event was due to excessive force during insertion.A summary of the investigation has been sent to the complainant.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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