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Model Number DRIVER SHAFT, T-15, LONG |
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 11/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint is confirmed.Functional testing was not performed on the returned ar-9545-t15-03 due to the damage to the device.Visual evaluation was performed, and noted the driver tip is twisted/bent.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause is attributed to over-torquing/over-engaging the driver with the screw head.Refer to the investigation photos.
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Event Description
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On 11/10/2023, it was reported by a sales representative via sems-06398499 that an ar-9545-t15-03 driver shaft tip is bent.This was discovered during use in a case with no patient harm."items did not affect the outcome to the case or negatively impact the patient.All cases proceeded as normal.".
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Search Alerts/Recalls
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