UNKN EXTERNAL FIXATOR PIN

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT IN A CLINICAL OBSERVATION OF "THE JOURNAL OF BONE & JOINED SURGERY 2011, DISTAL TIBIAL PHYSEAL ARREST AFTER MENINGOCOCCAL SEPTICAEMIA" THAT THE TAYLOR SPATIAL FRAME (SMITH & NEPHEW) WAS APPLIED TO 6 PATIENTS AND 3OF THESE PATIENTS PRESENTED PIN SITE INFECTION. IT IS UNKNOWN HOW THIS COMPLICATION WAS TREAT.

Additional Manufacturer Narrative

H3, H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE DATA PRESENTED IN THE AGED ARTICLE DID NOT PROVIDE INSIGHT OR RELEVANCE TO CURRENT CLINICAL OUTCOMES FOR THE PRODUCT/DEVICE. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES ARE REQUIRED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. POSSIBLE CAUSES COULD INCLUDE BUT NOT LIMITED TO CONTAMINATION, PATIENT REACTION, AND POST-OPERATIVE HEALING ISSUE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. 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.