Catalog Number 0210010100 |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/20/2014 |
Event Type
malfunction
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Event Description
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It was reported that the coaxial bone cleaning tip was being used in a procedure when the tip came detached in the middle and fell off.It was confirmed that the tip or no fragments from the tip fell into the surgical site.The procedure was completed successfully with the use of a back up device.There were no patient or user injuries, and no adverse consequences.
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Manufacturer Narrative
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The reported unit was not available to the manufacturer for evaluation.Only the unit¿s pouch with label was received.Therefore, the claimed condition could not be confirmed.Not available for evaluation.
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Event Description
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It was reported that the coaxial bone cleaning tip was being used in a procedure when the tip came detached in the middle and fell off.It was confirmed that the tip or no fragments from the tip fell into the surgical site.The procedure was completed successfully with the use of a back up device.There were no patient or user injuries, and no adverse consequences.
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Manufacturer Narrative
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A follow up report will be filed after the device is received and the quality investigation has been completed.Device not yet received by manufacturer.
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Search Alerts/Recalls
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