(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Visual examination of the returned product confirms the fixed foot has fractured from the main body.The product was returned dismantled and not complete.Two screws and the blue pad were missing.The instrument exhibits indentations on the top of the main body suggesting excessive use of the toffee hammer during insertion/impaction.The instrument has been potentially used in the field for approximately 5 years and 6 months.The reported event does not indicate a manufacturing issue.No further investigation action will be required as the additional information does not affect the previously completed investigation.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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(b)(4).Visual examination of the provided pictures identified the hook had partially sheared from the body of the instrument.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided however, the complaint description describes minor surgical delay whilst an alternative instrument is sourced without further discussion on further outcome.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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