Catalog Number 254401006 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 05/27/2015 |
Event Type
malfunction
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Event Description
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The attune impactors are cracked.Update-jun 4, 2015 - upon product receive and evaluated, product 254401006 lot au3654033 been changed from damaged to broken changing the mdr decision.
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Manufacturer Narrative
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Additional narrative: 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.
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Manufacturer Narrative
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Conclusion and justification status: the complaint states the attune impactors are cracked.The investigation confirmed that one of the impactor had cracked and the other had cracked and had a piece missing expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune femoral impactor has been annealed to reduce residual stresses.Lab tests indicate significant reduction in residual stresses of annealed samples in comparison to un-annealed samples however a complete reduction in stresses is not achievable.The annealed product was released on (b)(6)-2014.This device is from an un-annealed batch.A field safety notice was issued in nov 2014 stating to reduce the possibility of leaving fragments in patients, the company suggests adhering to the instructions for use (ifu), which include inspecting the impactor¿s to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.It should be noted that capa-(b)(4) has been initiated and can be referenced for further details.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.
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Search Alerts/Recalls
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