Catalog Number 254401017 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 08/31/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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During impaction of the cemented femoral implant, the retaining clip on the attune impaction handle((b)(4) lot nw143596) broke.All pieces were retrieved and the case continued.
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Manufacturer Narrative
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Conclusion and justification status: the complaint states during impaction of the cemented femoral implant, the retaining clip on the attune impaction handle(d254401017 lot nw143596) broke.All pieces were retrieved and the case continued.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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