Catalog Number 254401017 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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The level on the attune impaction handle broke, releasing the spring.
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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.
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Manufacturer Narrative
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Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.Conclusion and justification status: the complaint states the level on the attune impaction handle broke, releasing the spring.The investigation confirmed that the lever had broken as reported.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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