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 05/26/2014 |
Event Type
malfunction
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Event Description
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It was reported that 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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Event Description
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It was reported that 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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The returned device was confirmed to be producing metal shavings.Based on the manufacturing engineer¿s evaluation of the device, the source of the metal shavings was determined to be the ram bushings.The device was repaired and returned to the user facility.
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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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