GII TIBIAL BASE IMPACTOR

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). ADDITIONAL INFORMATION: H11: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. A VISUAL INSPECTION OF THE RETURNED DEVICE FINDS THE DEVICE WAS RETURNED WITH THE BUMPER FRACTURED IN SEVERAL PLACES. THE ENTIRE DEVICE IS WORN FROM USE. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED PART NUMBER OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. 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 THIS EVENT WAS PREVIOUSLY IDENTIFIED AND ADDRESSED; THE FOLLOWING ACTIONS WERE TAKEN: A STRESS RELIEF PROCESS WAS ESTABLISHED FOR PLASTIC BUMPERS, SAMPLES WERE TESTED, DEVICE MASTER RECORD FOR ALL PLASTIC BUMPERS WERE REVISED TO INCLUDE THE STRESS RELIEF OPERATION IN THE MANUFACTURING FLOW AND TO INCLUDE THE INSPECTION OF STRESS RELIEF TEMPERATURE CHART TO DETERMINE COMPLIANCE. THE LISTED BATCH WAS MANUFACTURED BEFORE CORRECTIVE ACTION IMPLEMENTATION. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY POTENTIAL FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. 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.

Description of Event or Problem

IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII TIBIAL BASE IMPACTOR WAS CRACKED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE 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 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.