Catalog Number 3572-2 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi number: ni.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 zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.
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Manufacturer Narrative
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Additional information: the returned device was evaluated.The torque output was confirmed to be outside of the range.The cause of this issue is likely attributed to a lack of regreasing/relubrication from repetitive use.A review of the manufacturing records did not identify any issues which may 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 zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.
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Search Alerts/Recalls
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