Conclusion and justification status: the complaint states during the inspection of the attune returned loan kit, the orthokit technician noted that : - the attune impactor was broken.- one spring is missing on the spacer block.- one spring was deformed.The investigation confirmed that the failure modes as reported.With regard to the impactor: 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 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.With regard to the spacer block: care needs to be used when assembling these connections, as damage may occur resulting in the type of failure seen here.However, there is insufficient information supplied with this complaint to determine whether sufficient care was or was not taken.It should be noted that pra 103033579 was released on 08 jul 2014 in which the damage to the balseals was evaluated.The pra concluded that there is no patient harm as none of the failure modes have led to any patient harm.Furthermore, the assembly and disassembly of this device is carried out by the scrub nurse on a table away from the joint space, additionally the device cannot be disassembled within the joint space.It should also be noted that this issue will be further monitored in post market surveillance the complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.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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