Catalog Number 0206600000 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/11/2014 |
Event Type
malfunction
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Event Description
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During inspection at the user facility, the dual speed cement injection gun was producing metal shavings.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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Based on the manufacturing engineer¿s evaluation of the device, the cause was determined to be the rod catching on the bushings due to interference.The device was repaired and returned to the user facility.
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Event Description
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During inspection at the user facility the dual speed cement injection gun was producing metal shavings.It was reported that there was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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A follow up report will be filed after the quality investigation has been completed.
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Search Alerts/Recalls
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