Zimmer biomet complaint (b)(4).Medical product: biomet microfixation ribfix blu system 90° contra angle driver catalog #: 24-1189 lot #: 191750.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: 0001032347-2018-00400.
|
Complaint sample was evaluated and the reported event was confirmed.The 90 degree contra angle screwdriver (part# 24-1189, lot# 191750) and contra angle temporary fixation screw (part# 76-0017, lot# 632390) were returned in a red biohazard bag.Visual inspection showed that the parts showed signs of wear, with some minor discoloration.The interface between the screwdriver and the screw also appeared rusty.The temporary fixation screw 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.There are no indications of manufacturing defects.Root cause was unable to be determined.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: 0001032347-2018-00400-1.
|