Catalog Number 07.02118.001 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check by the supplier.There are no specific surgical procedures associated with this handle.
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Manufacturer Narrative
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The device was not returned for evaluation so no results are available and no conclusions can be drawn.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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Event Description
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It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check by the supplier.There are no specific surgical procedures associated with this handle.
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Search Alerts/Recalls
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