Catalog Number 046W1AN00650 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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.Reference reports 3003853072-2018-00038 through 3003853072-2018-00040.
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Event Description
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It was reported that a torque limiting handle did not limit the torque applied to two blockers during surgery, and the threads on both blockers were damaged.The procedure was completed using alternative blockers.There were no reports of patient impacts associated with this event.This is report three of three for this event.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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Udi number: (b)(4).The returned torque limiting handle was evaluated.There were no signs of damage or malfunction found.The torque output was verified to meet specifications.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 a torque limiting handle did not limit the torque applied to two blockers during surgery, and the threads on both blockers were damaged.The procedure was completed using alternative blockers.There were no reports of patient impacts associated with this event.This is report three of three for this event.
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Search Alerts/Recalls
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