Catalog Number 3558-50 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that the tip of a driver broke off in a screw head while adjusting the height of the screw during surgery.The screw was removed and replaced with an alternative screw to complete the procedure, so the patient did not retain the device fragment.There were no reported patient impacts associated with this event.
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Manufacturer Narrative
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Udi number: na.Additional information: method, results, and conclusions - the returned driver was examined.A portion of the tip has fractured off of one side, indicating that an off-axis force was applied to the device during usage.There were no manufacturing issues detected which would have contributed to this event.
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Event Description
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It was reported that the tip of a driver broke off in a screw head while adjusting the height of the screw during surgery.The screw was removed and replaced with an alternative screw to complete the procedure, so the patient did not retain the device fragment.There were no reported patient impacts associated with this event.
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Search Alerts/Recalls
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