(b)(4).This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a5, b4, b5, d9, g3, g6, h1, h2, h3, h6, h10 visual examination of the returned product confirms the distal foot has fractured.The fractured piece was not returned with the product.The instrument exhibits indentations on the top of the main body suggesting excessive use of the toffee hammer during insertion/impaction.There is also evidence of indentations on the back side of the instrument suggesting use of the toffee hammer in the anterior to posterior direction.Review of the device history record identified no deviations or anomalies during manufacturing.Device is 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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