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 03/15/2018 |
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.Reference report 3003853072-2018-00008.
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Event Description
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It was reported that the torque limiting mechanism on a handle malfunctioned during surgery and caused the mating driver to break.The procedure was able to be completed using these two instruments without reported patient impacts.This is report two of two for this event.
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Manufacturer Narrative
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The returned handle was sent to an external laboratory for torque analysis.The torque readings were found to be in tolerance.There were no device malfunctions detected.
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Event Description
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It was reported that the torque limiting mechanism on a handle malfunctioned during surgery and caused the mating driver to break.The procedure was able to be completed using these two instruments without reported patient impacts.This is report two of two for this event.
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Manufacturer Narrative
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Udi number: (b)(4).The device was not returned so an evaluation is unable to be performed, no results are available, and no conclusions can be drawn.A review of the dhr did not find any manufacturing-related issues that would have contributed to this event.However, the handle was not returned for recalibration upon its due date in june 2017 despite requests to have it returned for calibration.
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Search Alerts/Recalls
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