Catalog Number 0940023000 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A partial blade was returned for evaluation.A follow up report will be filed once the quality investigation is complete.
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Event Description
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It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece castcutter.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
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Manufacturer Narrative
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Investigation results concluded that misloading of the device was a contributing factor to the fracture of the blade.The ifu for devices associated with the blade state the following "before operating the equipment, always make sure the blade is securely installed and the blade retention screw is tight.An improperly tightened screw may come loose and cause the blade to fracture".
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Event Description
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It was reported that during service conducted at the manufacturer a broken piece of a blade was found inside the handpiece castcutter.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
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Search Alerts/Recalls
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