(b)(4).Report source: foreign: (b)(6).Study: koo lee et al : a specialized fibular locking plate for lateral malleolar fractures.Information was received via a clinical study.Attempts were made to obtain additional information but were unsuccessful.Below are the results of the investigation: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Devices are used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Reference report: 0001822565-2021-01397.
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