This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h6, h10 visual examination of the returned product confirmed the identity of the product and also confirmed the reported fracture at the tip of the instrument.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The device was returned to the supplier for evaluation.The supplier tested the hardness and determined the value was within the specifications.The supplier also stated the fracture point shows that the instrument was not used according to the purpose and the instrument must not be used as a level.Due to the special shape, an over-strengthening of the tip can cause breakage.No medical records were supplied with the complaint, therefore no comments can be made regarding the surgical technique.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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