(b)(4).Concomitant medical devices: blunt tip screw, 4x40mm; item# 47248604040; lot# 3078169, blunt tip screw, 4x46mm; item# 47248604640; lot# 3073670, blunt tip screw, 4x46mm; item# 47248604640; lot# 3073796, blunt tip screw, 4x60mm; item# 47248606040; lot# 3078177, cortical bone screw, 4x26mm, item# 47248612640; lot# 3091272, cortical bone screw, 4x28mm; item# 47248612840; lot# 3081956, washer small; item# 47248800004; item# 3006468, washer small; item# 47248800004; item# 3006494, proximal humerus nail cap, 0mm; item# 47248801000; lot# 3082133, torque limiting handle; item# 27923; lot# unknown.Foreign source: japan.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00473, 0009613350 - 2022 - 00474, 0009613350 - 2022 - 00475, 0009613350 - 2022 - 00476.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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This follow-up report is being submitted to relay additional information.As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.No medical notes were provided.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behavior or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.The investigation also considered whether the design limitation of the corelock mechanism could be a potential contributing factor.However, further biomechanical testing identified that the product performance is in an acceptable range in comparison with legally marketed similar devices.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.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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