CONMED

Additional Manufacturer Narrative

THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE C2610, CANCELLOUS SCREW, 6.5 X 25 MM DEVICE WAS USED IN AN ACL RECONSTRUCTION SURGERY ON AN UNKNOWN DATE AND IT WAS FOUND POST-OPERATIVELY THAT ¿A PATIENT WHO WAS TREATED USING OUR PRODUCT (CANCELLOUS SCREW 6.5 MM) IN COMBINATION WITH THE SMITH & NEPHEW ENDOBUTTON IS REPORTEDLY EXPERIENCING SOME KIND OF ABNORMALITY IN THE SKIN AROUND THE KNEE WHERE THE IMPLANT WAS PLACED. AT PRESENT, IT IS UNCLEAR WHETHER THE OBSERVED CONDITION IS DIRECTLY RELATED TO THE IMPLANTED DEVICES. HOWEVER, THE CURRENT SITUATION SUGGESTS THAT IT WOULD MORE LIKELY BE RELATED TO THE PATIENT¿S INDIVIDUAL SENSITIVITY OR BIOLOGICAL RESPONSE TO THE IMPLANT MATERIAL, RATHER THAN TO A PRODUCT DEFECT.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, AND WITH NO INTRA-OPERATIVE ISSUES REPORTED. TO DATE, THERE IS NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. FURTHER INFORMATION WAS REQUESTED BUT WAS NOT MADE AVAILABLE. IT WAS REPORTED THAT DEVICE REMOVAL "IS EXPECTED TO BE CONSIDERED IN THE FUTURE, BUT THE DETAILS ARE UNKNOWN". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF AN UNDEFINED SKIN ABNORMALITY NEAR THE SITE OF DEVICE PLACEMENT; CONMED JAPAN IS REPORTING THIS EVENT, AND PER CSOP08.5003 REV. AL, SECTION 6.9, A MEDWATCH REPORT WILL BE FILED IN CONJUNCTION WITH ALL ADVERSE EVENTS OCCURRING OUTSIDE THE UNITED STATES.

Additional Manufacturer Narrative

NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE TI 6AL 4V ALLOY CONSISTS PRIMARILY OF TITANIUM, WITH CONTROLLED SMALL AMOUNTS OF NITROGEN, CARBON, HYDROGEN, IRON, AND OXYGEN, WHILE ALUMINUM (5.5¿6.75%) AND VANADIUM (3.5¿4.5%) SERVE AS THE MAIN ALLOYING ELEMENTS. THE RESULTS OF THE BIOCOMPATIBILITY TESTING DEMONSTRATE THAT CONMED LINVATEC TITANIUM PRODUCTS MEET THE REQUIREMENTS DELINEATED IN ISO 10993-1, 3, 4, 5, 6, JO, AND 12, ARE BIOCOMPATIBLE, AND DO NOT POSE A TOXIC RISK. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF 1 DEVICE FOR THIS LOT NUMBER AND FAILURE MODE. A DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS REPORTED EVENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF ONE REPORT, REGARDING ONE DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 6,749 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.0002. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE DEVICE IS CONTRAINDICATED FOR THOSE WITH: FOREIGN-BODY SENSITIVITY - WHERE MATERIAL SENSITIVITY IS SUSPECTED, APPROPRIATE TESTS SHOULD BE MADE AND SENSITIVITY RULED OUT PRIOR TO IMPLANTATION. PATIENT SHOULD BE ADVISED THAT PRODUCT MATERIALS MAY CAUSE ALLERGIC REACTIONS INCLUDING BUT NOT LIMITED TO, FOREIGN BODY REACTION, TISSUE IRRITATION/INFLAMMATION OR OTHER ALLERGIC REACTIONS. WHERE MATERIAL SENSITIVITY IS SUSPECTED, APPROPRIATE TESTS SHOULD BE MADE AND SENSITIVITY RULED OUT PRIOR TO IMPLANTATION.7. ANY DECISION TO REMOVE THE DEVICE SHOULD TAKE INTO CONSIDERATION OF THE POTENTIAL RISK TO THE PATIENT OF A SECOND SURGICAL PROCEDURE. IMPLANT REMOVAL SHOULD BE FOLLOWED BY ADEQUATE POSTOPERATIVE MANAGEMENT. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE C2610, CANCELLOUS SCREW, 6.5 X 25 MM DEVICE WAS USED IN AN ACL RECONSTRUCTION SURGERY ON AN UNKNOWN DATE AND IT WAS FOUND POST-OPERATIVELY THAT ¿A PATIENT WHO WAS TREATED USING OUR PRODUCT (CANCELLOUS SCREW 6.5 MM) IN COMBINATION WITH THE SMITH & NEPHEW ENDOBUTTON IS REPORTEDLY EXPERIENCING SOME KIND OF ABNORMALITY IN THE SKIN AROUND THE KNEE WHERE THE IMPLANT WAS PLACED¿. AT PRESENT, IT IS UNCLEAR WHETHER THE OBSERVED CONDITION IS DIRECTLY RELATED TO THE IMPLANTED DEVICES. HOWEVER, THE CURRENT SITUATION SUGGESTS THAT IT WOULD MORE LIKELY BE RELATED TO THE PATIENT¿S INDIVIDUAL SENSITIVITY OR BIOLOGICAL RESPONSE TO THE IMPLANT MATERIAL, RATHER THAN TO A PRODUCT DEFECT.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, AND WITH NO INTRA-OPERATIVE ISSUES REPORTED. TO DATE, THERE IS NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. FURTHER INFORMATION WAS REQUESTED BUT WAS NOT MADE AVAILABLE. IT WAS REPORTED THAT DEVICE REMOVAL "IS EXPECTED TO BE CONSIDERED IN THE FUTURE, BUT THE DETAILS ARE UNKNOWN". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF AN UNDEFINED SKIN ABNORMALITY NEAR THE SITE OF DEVICE PLACEMENT; CONMED JAPAN IS REPORTING THIS EVENT, AND PER CSOP08.5003 REV. AL, SECTION 6.9, A MEDWATCH REPORT WILL BE FILED IN CONJUNCTION WITH ALL ADVERSE EVENTS OCCURRING OUTSIDE THE UNITED STATES.