Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2021-00002.Medical products: 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, lot# 893690 2.0 lactosorb system 2.5 x 7mm direct drive screw, part# 915-2208, lot# 769250 the user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
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This follow-up report is being submitted to relay additional information.One screw from lot 769250 was returned with the head and threads damaged and covered in blood.Two screws from lot 893690 were returned.One is fractured and the other is deformed and covered in blood.Item and lot numbers are confirmed to match the complaint with package labels.Dimensional testing was not completed due to damage to the screw head.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined due to the inability to dimensionally measure the product because of the product damage.A possible gauge issue was identified and an issue evaluation was previously initiated for further evaluation.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.This report is being submitted to update additional information in section b5, d4, d9, d10, h2, h3, h6 and h10.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00002, 0001032347-2021-00238 d11 ¿ medical products 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, lot# 893690 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, lot# 893690.
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