It was reported that the battery housing has a broken locking mechanism, which is causing the inability to open and close the device.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, in this case no further outcome was reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr review was performed.Device was 99 months old and is not out-of-the-box failure.A 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.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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