(b)(4).Medical devices: oxf twin-peg cmntd fem sm pma item#: 161468 lot#: 649630, oxf uni tib tray sz c lm pma item#: 154722 lot#: 013320, pulsavc plus fan spray kit int item#: 00-5150-475-01 lot#: 64826482, quick-vac mixing bowl single item#: 00-5049-001-00 lot#: 56518519, oxf sawblade stryker cmntd 3pk item#: 506298 lot#: 362651.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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00391 and 3002806535-2022-00393.
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No products were returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records were not provided.A definitive root cause cannot 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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