Zimmer biomet complaint (b)(4).Medical product: biomet microfixation ribfix blu system temporary fixation screw, contra angle catalog #: 76-0017, lot #: 632390.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 report: 0001032347-2018-00427.
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Complaint sample was evaluated and the reported event was confirmed.The 90 degree contra angle screwdriver (part# 24-1189, lot# 490190) and contra angle temporary fixation screw (part# 76-0017, lot# 632390) were returned in a red biohazard bag.Visual inspection showed that the screwdriver was discolored.The temporary fix screw was significantly bent and could not be released from the screwdriver collet.The screwdriver was not disassembled due to the fact that it was returned in a biohazardous condition.Further functional tests and inspections could not be performed due to the bio hazardous state of the product.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to 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 report: 0001032347-2018-00427-1.
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