The reason for this revision surgery was due to the patient's knee being tight.The previous surgery and the revision detailed in this investigation occurred 11 months apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was not made available to djo surgical for examination.A review of the device history record (dhr) revealed one non-conforming material report (ncmr) associated with the component listed in the complaint.Non-conforming material report (ncmr) # (b)(4) was for rework of 20 parts for unacceptable sterilization cycle.After rework the device history record (dhr) shows that all critical dimensions and proper sterilization were met at the time of release from djo surgical.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to the patients knee was tight.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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