It was reported that outside of surgery, the product arrived with a damaged battery pack.The contents of the battery exploded on the device.The account believes the debris was caused by the battery compartment which appears to have burst.There was no patient involvement.Due diligence is complete, no further information is available.
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This event has been recorded by zimmer biomet under cmp-(b)(4).The following sections have been corrected/updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and, h10.Visual inspection of the provided pictures determined there was black debris throughout the tray.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to manufacturing issue.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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