Catalog Number UNK_INS |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/09/2015 |
Event Type
malfunction
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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 saw.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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A partial blade and the associated handpiece saw (6209000000, sn (b)(4)) subject to this investigation were returned to the manufacturer for evaluation.It was visually confirmed that a partial piece of the unknown blade was broken.The piece of the blade returned was confirmed to be a broken eyelet(rings) which is one of the interface points where the blade connects with the handpiece.The associated handpiece evaluation observed an issue with the blade fit assembly in the handpiece, which may potentially cause or contribute to the blade break.
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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 saw.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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A follow up report will be filed once the quality investigation is complete.
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Search Alerts/Recalls
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