CMRH HEAD SZ. 22

Additional Manufacturer Narrative

H10: 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, DURING A RADIAL HEAD REPLACEMENT SURGERY, ONE (1) CMRH HEADS SZ. 22 WAS SPINNING ON THE STEM AFTER IMPACTION. SURGEON REPLACED IT WITH ANOTHER CMRH HEADS SZ. 22 AND A LONGER STEM, BUT THE HEAD STILL SPUN JUST THE SAME. AFTER REMOVING THE FIRST STEM, A SMALL RADIAL NECK FRACTURE OCCURRED. THE SURGEON DETERMINED THAT CABLING WAS UNNECESSARY, AS THE IMPLANT SEATED PROPERLY ON THE CORTEX. THE PROCEDURE WAS COMPLETED, AFTER A 40-MINUTE DELAY, WITH A S+N BACK-UP DEVICE. THE PATIENT'S CURRENT HEALTH STATUS IS STABLE.

Additional Manufacturer Narrative

THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE FINDS THE PYROCARBON HEAD AND FORMED INSERT ON AN UNIDENTIFIED STEM. THE PYROCARBON DEVICE IS FRACTURED, SCUFFED, SCRATCHED AND THERE IS A SMALL AMOUNT OF THE POLISHED SURFACE FLAKED OFF IN LINE WITH THE FRACTURE. ADDITIONALLY, THE EDGES ARE DEFORMED, WHICH WAS ALSO CONFIRMED IN THE VIDEO PROVIDED BY THE CUSTOMER. THE RESEARCH AND DEVELOPMENT TEAM CONCLUDED THAT THERE HAVE BEEN NO RECENT DESIGN CHANGES TO THE IMPLANT. ADDITIONALLY, IT IS NOTED THAT THE STEM CANNOT BE REMOVED FROM THE HEAD WITHOUT DAMAGING OTHER PARTS. ACCORDING TO SPECIFICATION, AFTER ASSEMBLY, A FUNCTIONAL CHECK TO VERIFY THAT THE INSERT DOES NOT FREELY ROTATE IS PART OF THE STEPS CARRIED. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A LABORATORY ANALYSIS PERFORMED ON THE DEVICE REVEALED THAT UPON EXAMINATION, IT COULD BE OBSERVED THAT THE CHIPPED OFF PIECE FROM THE SURFACE OF THE PYROCARBON HEAD IS IN LINE WITH THE PROPAGATED FRACTURE. GIVEN THIS FINDING, IT CANNOT BE RULED OUT THAT THE FRACTURE MAY HAVE INITIATED IN THE SPOT OF SAID CHIPPED OFF PIECE DUE TO AN INTERACTION WITH AN INSTRUMENT USED IN THE PROCEDURE. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD 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.