Catalog Number 254401017 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 09/24/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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Attune impaction handle broke during the case.The pin on the side part of the device that holds attachments became loose and slides in and out of the handle.
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Manufacturer Narrative
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Conclusion and justification status: the complaint states attune impaction handle broke during the case.The pin on the side part of the device that holds attachments became loose and slides in and out of the handle.The investigation could not confirm the complaint as no product was returned it should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.The complaint shall be closed to capa; it will be entered into the complaint database and monitored through trend analysis.
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Search Alerts/Recalls
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