BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED CLINICAL INFORMATION PROVIDED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES THAT THE EVENT WAS MANAGED WITH MEDICATION, AFTER WHICH THE SUBJECT REPORTEDLY RECOVERED. ALTHOUGH REQUESTS WERE MADE, SUPPORTING MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. BASED ON THE LIMITED INFORMATION PROVIDED, THE CLINICAL ROOT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. SINCE NO FURTHER HARM IS ANTICIPATED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. BASED ON THE LIMITED INFORMATION PROVIDED WE ARE UNABLE TO CONCLUDE ON FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT AFTER A SHOULDER ARTHROSCOPY TO TREAT A PARTIAL-THICKNESS TEAR, PERFORMED ON (B)(6) 2024 USING A BIOINDUCTIVE IMPLANT, THE CLINICAL SUBJECT EXPERIENCED PAIN. THE PATIENT WAS NOT ABLE TO RECALL THE DATE OF THE EPISODE OF PAIN. THE ISSUE WAS TREATED WITH A DOSE OF CODYDRAMOL. THE CLINICAL SUBJECT IS RECOVERED.