Correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is 3016573902.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient showed signs of infection.Probable root cause: design: wrong raw material or manufacturing agent selected, in-process cleaning not effective at removing manufacturing residuals, not enough strict controls placed on raw material source and purity.Process: sterilization fault - including eto residuals, contamination during manufacturing process; including endotoxins, in-process cleaning not performed to spec (i.E.Residues and leachable dcm, ethanol and acetone).Application: contamination of instruments, patient reaction/allergy sensitivity or with active/latent infection, use of contrast media, use of more than one implant within the shoulder, wrong patient selection.The device manufacturer date is not known.
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