Zimmer biomet complaint (b)(4).Unique identifier (udi) number: (b)(4).Complaint sample was evaluated and the reported event was not confirmed.The product identities were confirmed.The sternalock blu system blade, sternalock (part# 73-1194, lot# 859370, 577770) were visually evaluated.Both blades showed signs of moderate use with some wear and tear at the part of the shaft that interfaces with a driver collet.There was also some minor discoloration at the tips.The blades were functionally tested by inserting them into a driver (part# 46-0008) and into a 2.4mm screw (part# 76-2410), then lifting the assembly by the screw to test the blades' retention.Both blades passed the retention test and were also able to drive the screw into a block of white oak wood.Device history record (dhr) was reviewed and no discrepancies were found.The complaint was not confirmed as the device analysis indicated that the device met specification.There are no indications of manufacturing defects.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: 0001032347-2019-00021-1, 0001032347-2019-00022-1, 0001032347-2019-00023-1, and 0001032347-2019-00024-1.
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