UNKN EXTERNAL FIXATOR PIN

Additional Manufacturer Narrative

THE DEVICE, USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED AT THIS TIME. SO THE REPORTED EVENT COULD NOT BE CONFIRMED. A MEDICAL INVESTIGATION WAS CONDUCTED AND CONFIRMS DURING THE STUDYING IT WAS REPORTED THAT THE PATIENT DEVELOPED A SUPERFICIAL PIN INFECTION. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. INFECTION, A POTENTIAL COMPLICATION ASSOCIATED WITH ANY SURGERY, CAN OCCUR AND POSSIBLE CAUSES COULD INCLUDE BUT NOT LIMITED TO CONTAMINATION, PATIENT REACTION, AND POST-OPERATIVE HEALING ISSUE. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICE OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

Additional Manufacturer Narrative

CASE-(B)(4).

Description of Event or Problem

IN THE PAPER: "STRATEGIES IN TRAUMA AND LIMB RECONSTRUCTION 2019. OUTCOMES FOLLOWING TREATMENT OF COMPLEX TIBIAL FRACTURES WITH CIRCULAR EXTERNAL FIXATION: A COMPARISON BETWEEN THE TAYLOR SPATIAL FRAME AND TRUELOK-HEX" AUTHOR: JACO NAUDE ET AL. IN THIS STUDY THERE WERE 45 PATIENTS, 21 BEARING TSF. IT WAS REPORTED THAT A PATIENT SUFFERED FROM SUPERFICIAL PIN INFECTIONS. IT IS UNKNOWN HOW THE EVENT WAS TREATED.