Catalog Number 62422603 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it was reported that a automatrix shaft broke during use; no injury resulted.
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Manufacturer Narrative
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Returned product confirmed to be a flexshaft with date code 0621.Returned product observed had a "weld" failure, this is caused when the welding stage of the manufacturing processes is not executed correctly and/or the weld did not hold up after use.The welder is to secure the hex sleeve to the flexible sleeve to create the sub-assembly.If the weld is not secure/successful, the device may become compromised and non-conforming., therefore this complaint is considered substantiated.
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Search Alerts/Recalls
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