Catalog Number 254401003 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 06/29/2015 |
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.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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Maude report mw5043904: surgeon was using the attune fb impactor instrument during a total knee replacement and it broke in half.No retained pieces left in the surgical wound.J and j depuy rep present in operating room at time of device failure and aware.Device sequestered.
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Manufacturer Narrative
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Conclusion and justification status: the complaint states surgeon was using the attune fb impactor instrument during a total knee replacement and it broke in half.No retained pieces left in the surgical wound.J and j depuy rep present in operating room at time of device failure and aware.Device sequestered.No product was returned and hence the complaint could not be confirmed expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune fb tibial 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.This device is from an 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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