A REVIEW OF THE DEVICE LOT HISTORY RECORDS WAS PERFORMED. BASED ON THAT REVIEW, THE NON-CONFORMANCES COULD NOT HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE. ALL THIRTEEN (13) DEVICES RELEASED FROM THE LOT WERE MANUFACTURED TO SPECIFICATIONS. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED DEVICE LOT NUMBER. A REVIEW OF THE IFU INDICATED THAT ?INFECTION, ALLERGIC REACTION, AND ACUTE OR CHRONIC INFLAMMATION (INITIAL APPLICATION OF SURGICAL GRAFT MATERIALS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION)? ARE POTENTIAL COMPLICATIONS. THE IFU ALSO NOTES THAT IF THESE ?CONDITIONS OCCUR AND CANNOT BE RESOLVED, CAREFUL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED." A REVIEW OF THE PATHOLOGY REPORT WAS PERFORMED BY COOK RESEARCH INCORPORATED?S VETERINARY PATHOLOGIST. THE REVIEW INDICATED THAT THE TISSUE CHANGES WERE COMPATIBLE WITH HEALING CHANGES AT FOUR (4) WEEKS POST-OP. THE ACUTE INFLAMMATION IN THE FLEXOR TENDON AND THE FIBRINOID NECROSIS AND ACUTE NEUTROPHILIC INFLAMMATION IN THE NERVE WRAP SUGGESTED A POST-OP BACTERIAL INFECTION. THE CHRONIC INFLAMMATION AND PALISADING GRANULOMATOUS INFLAMMATION COULD INDICATE THE INFECTION WAS PRESENT FOR AT LEAST 2 WEEKS. HOWEVER, TO A SMALL DEGREE, CHRONIC INFLAMMATION IS NORMAL PART OF TISSUE REMODELING WITH SIS. THE ROOT CAUSE, OF THE PATIENT?S POST-OP EXPERIENCE, WAS LIKELY RELATED TO A POST-OPERATIVE BACTERIAL INFECTION. THE AXOGUARD NERVE PROTECTOR, AS PROVIDED TO THE USER, UNLIKELY CAUSED OR CONTRIBUTED TO THE INFECTION. COOK BIOTECH INCORPORATED HAS A VALIDATED STERILIZATION CYCLE WITH A STERILITY ASSURANCE LEVEL OF (SAL) 10^-6. THE VALIDATED STERILITY CYCLE AND ALL PARAMETERS OF ALL DEVICES ARE VERIFIED PRIOR TO RELEASE FOR DISTRIBUTION. POSSIBLE CONTRIBUTING FACTORS, TO THE PATIENT?S WOUND INFECTION, COULD INCLUDE, BUT IS NOT LIMITED TO A NOSOCOMIAL INFECTION, CONTAMINATION DURING THE SURGICAL PROCEDURE, OR INADEQUATE POST-OP CARE OF THE SURGICAL WOUND.
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Patient 1
ON (B)(6) 2017, DR. (B)(6) PLACED AN AXOGEN NERVE PROTECTOR IN A LEFT WRIST FOR A COMPARTMENTAL CARPAL TUNNEL REVISION. THIS WAS FOR TREATMENT OF RECURRENT CARPAL TUNNEL SYNDROME. THE DEVICE WAS HYDRATED FOR ONE (1) MINUTE. WOUND CLOSURE WAS ONE (1) LAYER WITH 4-0 SUTURE. THE PATIENT DEVELOPED INTENSE FLEXOR SYNOVITIS AT FOUR (4) WEEKS POST DEVICE IMPLANTATION. ON (B)(6) 2017, THE PATIENT UNDERWENT A FLEXOR SYNOVECTOMY AND THE NERVE PROTECTOR WAS EXPLANTED. THE EXPLANTED DEVICE WAS SENT FOR CULTURES AND PATHOLOGY. AT THE TIME THE FEEDBACK WAS REPORTED, THE SURGEON WAS UNCERTAIN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE NEED FOR REOPERATION ON (B)(6) 2017. THE PATHOLOGY RESULTS FOR THE LEFT WRIST SYNOVIUM OF THE LEFT FLEXOR TENDON SHOWED MILD ACUTE AND CHRONIC INFLAMMATION AND MARKED REACTIVE CHANGES. THE EXPLANT SHOWED SYNOVIAL TISSUE WITH REACTIVE CHANGES INCLUDING SYNOVIAL HYPERPLASIA, HYPERVASCULARITY, AND MILD FIBROSIS. IN ADDITION, MILD FOCAL ACUTE INFLAMMATION AND SCATTERED SMALL LYMPHOID AGGREGATES OF CHRONIC INFLAMMATION WERE SEEN. THE PATHOLOGY RESULTS FOR THE LEFT WRIST NERVE WRAP SHOWED MARKED ACUTE INFLAMMATION AND MARKED REACTIVE CHANGES. THE EXPLANT SHOWED FIBROVASCULAR TISSUE WITH FIBRINOID NECROSIS OF ONE SURFACE AND ASSOCIATED MARKED ACUTE INFLAMMATION WITH NUMEROUS NEUTROPHILS. FOCAL AREAS OF PALISADING GRANULOMATOUS REACTION WERE ALSO SEEN. THE UNDERLYING TISSUE SHOWED MODERATE-TO-MARKED CHRONIC INFLAMMATION WITH SCATTERED LYMPHOID AGGREGATES. BASED ON THE PATHOLOGY RESULTS, DR.(B)(6) REPORTED THAT SURGICAL INFECTION WAS NOT BELIEVED TO BE THE CAUSE OF THE OCCURRENCE, RATHER A TISSUE REACTION TO THE IMPLANT.