This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for the oscillating saw blade strykerâ® system 6, part number 562710601, review could not be performed as a lot number was not provided for the reported event.On (b)(6) 2019, it was reported from (b)(6) that an oscillating saw blade strykerâ® system 6 had the pin fall out causing the screw to be loose.The saw blade was broken.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can, therefore, not be confirmed.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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