While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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6-29-2023: product not returned, however image attached depicts an automate iii handle assembly with flexshaft installed (date code could not be verified with image) with coil deformation caused by weld failure rendering the product unusable.Capa-2021-375 opened to address weld failures, coil/spring tears/deformation and ¿broken tip¿ for product manufactured by sarasota since december 2020 (date code 1220) through implementation date of (b)(6) 2022 (0822).Batch 04961585 of item# (b)(4) utilized flexshaft assembly item (b)(4) batch 04908247 which was produced in october 2021 (date code 1021).(nwv) 7-3-2023: see attachment word document for dhr review and retain evaluation (limited to 1000 characters only in this text field).(nwv).
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