Additional narrative: the complaint is being confirmed for depth gauge for 2.0mm and 2.4mm screws (part# 319.006, lot# h363284).No definitive root cause could be determined based on the provided information.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # 319.006 , synthes lot # h363284, supplier lot # h363284, release to warehouse date: 21nov2017, supplier: avalign technologies-nemcomed.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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