Catalog Number 254401003 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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The attune fb tibial impactor broke while impacting the tibial component onto the tibia.
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Manufacturer Narrative
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The device associated with this report was not returned.Follow up communication for product return was unsuccessful.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 an unjustified conclusion; it will be entered into the complaint database and monitored through trend analysis.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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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.
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Manufacturer Narrative
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Conclusion and justification status: territory 213 reports the attune fb tibial impactor broke while impacting the tibial component onto the tibia.The device associated with this report was not returned.Follow up communication for product return was unsuccessful.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 (b)(4) has been initiated and can be referenced for further details.The complaint shall be closed with an unjustified conclusion; it will be entered into the complaint database and monitored through trend analysis.Addendum added 10 may 2016: the complaint was reopened as the product was returned.Upon inspection it was noted it had broken into two pieces.The above conclusion remains valid.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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