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Model Number DRIVER SHAFT, T6, SELF 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 11/17/2023 |
Event Type
malfunction
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Event Description
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On 11/17/2023, it was reported by a sales representative via sems-06404429 that (qty.2) of an ar-18800-03 driver shaft twisted despite the surgeon's use of the torque limiting adapter present in the set.They were told the devices twisted before the torque limiting adapter engaged.This was discovered during an unspecified procedure, with no reported patient harm.
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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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Search Alerts/Recalls
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