Catalog Number 254401017 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 09/10/2015 |
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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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During impaction of the tibial baseplate, the retaining clip on attune impaction handle broke during the final impact and fell on the floor.It didn't cause a delay to the case.No piece of instrumentation was left in the patient.
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Manufacturer Narrative
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Conclusion and justification status: the complaint states during impaction of the tibial baseplate, the retaining clip on attune impaction handle broke during the final impact and fell on the floor.It didn't cause a delay to the case.No piece of instrumentation was left in the patient.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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