It was reported that during surgery, a hair was found inside of the sterile tray when the nurse opened the sterile tray.There was no patient harm/injury.There was no medical intervention.There was a 0 -15 minute surgical delay for preparing an alternate device.Due diligence is complete, no further information is available.
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This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h10.The device was returned opened but unused.Visual inspection confirmed there was a long dark hair present inside the tyvek tray.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.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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