(b)(4).Concomitant medical products: 47249532011 62266723 tibial nail - yellow 11 mm diameter 32 cm length use red proximal and red distal screws; 47248403050 62321950 5.0 mm diameter cortical screw; 47248403550 62330386 5.0 mm diameter cortical screw; 47248403550 62340928 5.0 mm diameter cortical screw; 47248403050 62321950 5.0 mm diameter cortical screw; 47248405250 62214118 5.0 mm diameter cortical screw; 47248403550 62321879 5.0 mm diameter cortical screw.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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: 0001822565-2021-02531, 0001822565-2021-03070, 0001822565-2021-03542, 0001822565-2021-03543, 0001822565-2021-03544, 0001822565-2021-03547.
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review of the available records identified initial surgery noted poor bone quality additional cross-locking proximally.Revision surgery due to nail, plate must be attached obliquely, dorsolateral fragment remains.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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