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Model Number DRIVER SHAFT, T6, NON-RETAINING, AO |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On 3/20/2024, it was reported by an arthrex employee via sems (b)(4) that an ar-18800-04 driver shaft (from set ar-18800fs) threads were all twisted after completing the case and inspecting the tray.This was discovered after use on (b)(6) 2024, with no reported patient harm.
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Event Description
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Additional information was received on 3/25/2024: this was after a metatarsal fx procedure.
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Manufacturer Narrative
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Additional information: d9, b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
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Search Alerts/Recalls
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