If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Conclusion and justification status: the complaint states attune impactors are cracked and one is broken.The investigation confirmed that 2 of the impactors had broken and one had cracked.Expert opinion indicates that the failures are associated with environmental stress cracking (esc).The attune impactors have 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.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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