ROCKER RING

Additional Manufacturer Narrative

THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION BUT THE PICTURES WERE REVIEWED AND THE FAILURE MODE WAS CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE PROVIDED PHOTO CONFIRMS THE BROKEN ROCKER RING. HOWEVER, WITH THE REQUESTED CLINICAL INFORMATION FALL/TRAUMA HISTORY OR THE DEVICE THE ROOT CAUSE OF THE BREAKAGE CANNOT BE DETERMINED. PER SUBSEQUENT EMAIL. IT WAS REPORTED AFTER THE PATIENT WAS ADMITTED TO THE CLINIC FOR INTERVENTION, THE PATIENT IS HEALTHY, AND THE ISSUE HAS BEEN RESOLVED. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE RISK MANAGEMENT FILE AND INSTRUCTIONS FOR USE DOCUMENTS REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE BUT NOT LIMITED TO TRAUMATIC INJURY OR EXCESSIVE FORCES APPLIED TO THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER AN UNKNOWN PROCEDURE, IT WAS NOTICED THAT THE ROCKER RING BROKE IN THE BACK, AT THE S+N LOGO. PATIENT WAS ADMITTED IN THE CLINIC FOR MEDICAL INTERVENTION.