H10: (d4) catalog number: 351-90-24, serial number: (b)(6) , expiration date: 06-mar-2028, unique identifier (udi) #: (b)(4).(h3) the broken talar trial screw reported may have been the result of applying a bending moment while removing the screw from the talus, allowing it to fracture.However, this cannot be confirmed as the device was not returned for evaluation and x-ray images were not provided.(h4) device manufacture date: 08-mar-2019.(h6) evaluation codes: 3165, 1069.Section h11: the following sections have corrected information: (d2) common device name: talar trial screw pouch.(h1) type of reportable event: serious injury.(h5) labeled for single use?: yes.
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