(b)(4).Additional concomitant medical products: biomet microfixation ribfix blu system temporary fixation screw, contra angle catalog #: 76-0017, lot #: 828490.Therapy date: (b)(6) 2018.Product has been received by zimmer biomet and the investigation is in process.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: 0001032347-2018-00422 and 0001032347-2018-00424.
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Complaint sample was evaluated and the reported event was confirmed.The 90 degree contra angle screwdriver (part# 24-1189, lot# 056380 (qty 1), lot# 056370 (qty 1)) and the contra angle temporary fixation screw (part# 76-0017, lot# 828490 (qty 2)) were visually evaluated.The bodies and heads of the screwdrivers were discolored.The temporary fixation screws appeared to be in good condition, but the interfaces between the screws and the screwdrivers were also discolored.The screwdrivers were functionally tested by rotating the knob in both clockwise and counterclockwise directions.The screwdriver from lot# 056370 had minimal sticking during rotation and was squeaking.The screwdriver from lot# 056380 was completely seized and could not be rotated.Neither screwdriver would release the temporary screw from the collet.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the supplier using blades, and not the min/max gage, to design the collet resulting in the collet failing the max gage inspection.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: 0001032347-2018-00422-1 and 0001032347-2018-00424-1.
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