Catalog Number 254401006 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Conclusion and justification status: the complaint states attune femoral impactor cracked.The investigation confirmed that the impactor had broken as reported.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 30-jul-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 (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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Event Description
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Attune femoral impactor cracked.Update 04/07/2015-product received.Upon evaluation of the product, it has been determined the instrument is broken, changing the mdr decision.The complaint was updated 04/09/2015.
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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.
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Search Alerts/Recalls
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