BIOINDUCTIVE IMPLANT W/ARTH DEL LRG

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR 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 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 CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL 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 ROTATOR CUFF TENDON REPAIR SURGERY, THAT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED THAT A BIOINDUCTIVE IMPLANT SEPARATED OFF, THE UNIT DID NOT IMPLANT CORRECTLY, IT WAS LOOSE AND MIGRATED. THIS EVENT WAS SOLVED BY ANOTHER ARTHROSCOPY ON (B)(6) 2025 AND THE SURGEON HAD TO REMOVE THE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE (B)(4). H2: ADDITIONAL INFORMATION: B1, B2. H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 NO SIMILAR REPORTED EVENTS. 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. THE INSTRUCTIONS FOR USE WAS 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. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT IS RECEIVED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED FOR FURTHER ASSESSMENT.