The reason for this revision surgery was due to loose ulna.The previous surgery and the surgery detailed in this investigation occurred 1.5 years apart.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 disposed of at the hospital and not made available to djo surgical for examination.As of 22 may 2019, the device history record (dhr) for item: 114833 has not been made available or forwarded.Should the record become available, the complaint will be re-opened and a further review will be conducted.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 loose ulna.There were no findings during this investigation that indicate that the reported device was defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.
|