Conclusion and justification status: 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.The investigation confirmed that the impactor had cracked 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.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.Depuy still 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.
|