EXACTECH

Additional Manufacturer Narrative

AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH, FEI 1038671, HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. MFG DATE: 12/29/2012. (B)(4). CAPA (B)(4) -INVESTIGATION STATES: THE CAUSE OF THIS FAILURE COULD BE REPROCESSING OF THESE PARTS. IN ORDER TO UNDERSTAND WHY THESE DEVICES ARE FAILING IN SINGAPORE AND KOREA, A QUESTIONNAIRE WAS SENT TO THE SALES FORCE IN KOREA AND SINGAPORE TO INQUIRE ABOUT TKA TRIALING, GENERAL USE, AND STERILIZATION/REPROCESSING TECHNIQUES. ACCORDING TO AN EMAIL FROM THE SALES MANAGER AT EXACTECH KOREA, THESE INSTRUMENTS ARE BEING STERILIZED FOR 40-50 MINUTES AT 134 DEGREES (CELSIUS). THESE REPROCESSING METHODS ARE OUTSIDE OF EXACTECH'S RECOMMENDED STERILIZATION INSTRUCTIONS PER 700-096-057 - REPROCESSING INSTRUCTIONS FOR REUSABLE SURGICAL INSTRUMENTS, WHICH STATES PARAMETERS FOR STERILIZATION. (B)(4) IS THE INITIAL SCOPE ASSESSMENT. ROOT CAUSE: THE REPROCESSING OF THESE INSTRUMENTS EXCEEDS THE RECOMMENDED PARAMETERS LISTED IN THE REPROCESSING INSTRUCTIONS. THE MATERIAL DEGRADATION FROM EXCESSIVE STERILIZATION OF THESE INSTRUMENTS HAS LIKELY LED TO THE OBSERVED FAILURE. NO ADDITIONAL ACTION REQUIRED. IFU 700-096-181: INSTRUMENT INSPECTION · VISUALLY INSPECT THE INSTRUMENTS FOR DAMAGE SUCH AS FRACTURES; CRACKS; GOUGES; DEFORMATION; BURRS; DISCOLORATION, CORROSION, OR RUST; EXCESSIVE COMPONENT WEAR; NICKS ON CUTTING SURFACES, MISSING OR LOOSE COMPONENTS; BLOCKAGES IN CANNULAE, CLEANING HOLES OR OTHER CAVITIES THAT CANNOT BE REMOVED VIA STANDARD CLEANING; WORN OR DIFFICULT TO READ MARKINGS/ENGRAVINGS; OR OTHER APPARENT DAMAGE. · CHECK THE FUNCTION OF MECHANISMS BY ACTUATING ANY LEVERS, KNOBS, SWITCHES, CONNECTORS, SLIDING FEATURES, HINGES, OR OTHER MECHANICAL INTERFACE FEATURES. ENSURE SMOOTH OPERATION OF THESE FEATURES OVER THEIR FUNCTIONAL RANGE OF MOTION. · IF DAMAGE, WEAR, OR NON-FUNCTIONING/POORLY FUNCTIONING MECHANISMS ARE FOUND, DO NOT USE THE INSTRUMENT, AND CONTACT THE SALES REPRESENTATIVE OR CUSTOMER SERVICE FOR DISPOSITION. IFU STATES: THE SURGEON SHALL BECOME THOROUGHLY FAMILIAR WITH THE TECHNIQUE OF IMPLANTATION OF THE PROSTHESES BY: (1) APPROPRIATE READING OF THE LITERATURE, AND (2) TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR SURGERY, AND (3) REVIEWING INFORMATION REGARDING USE OF INSTRUMENTATION. IT IS A CLINICAL STANDARD OF PRACTICE IN THE OPERATING ROOM THAT ALL INSTRUMENTS SHOULD BE VISUALLY AND FUNCTIONALLY INSPECTED BEFORE USE, THESE GUIDELINES ARE FROM STANDARD ASSOCIATION OF PERI- OPERATIVE REGISTERED NURSES (AORN) GUIDELINES. SURGEONS ARE TO BE FAMILIAR AND KNOWLEDGEABLE WITH ALL INSTRUMENTATION, DEVICES AND PROFICIENT WITH SURGICAL TECHNIQUES. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED EVENT IS RELATED TO ANY MANUFACTURING ISSUES OR DESIGN ISSUES, NOR DID IT LEAD TO PATIENT ADVERSE EVENT. AN INVESTIGATION WAS CONDUCTED UNDER CAPA(B)(4); THE REPROCESSING OF THESE INSTRUMENTS EXCEEDS THE RECOMMENDED PARAMETERS LISTED IN THE REPROCESSING INSTRUCTIONS. THE MATERIAL DEGRADATION FROM EXCESSIVE STERILIZATION OF THESE INSTRUMENTS HAS LIKELY LED TO THE OBSERVED FAILURE. NO ADDITIONAL ACTION REQUIRED.

Description of Event or Problem

IT WAS REPORTED FROM OUS THAT DURING AN INITIAL IMPLANT PROCEDURE THE INSERT TRIAL BROKE DURING INSERTION OF THE IMPLANT. THE SURGEON DID THE LAST RANGE OF MOTION VERIFICATION AFTER INSERTION OF THE FEMORAL AND TIBIAL IMPLANTS, WHEN THE INSERT TRIAL WAS REMOVED IT BROKE. THE DEVICE BROKE INTO 2 LARGE PIECES AND WAS BEING HELD BY THE HANDLE, NOTHING FELL INTO THE SURGICAL SITE. THE SURGEON CONFIRMED THAT ALL BROKEN PIECES WERE ACCOUNTED FOR. THE PATIENT'S HEALTH WAS STABLE LEAVING THE OR. THE ISSUE WAS RESOLVED BY USING ANOTHER INSTRUMENT. THERE WAS NO DELAY OF THE PROCEDURE. THE AGENT WAS PRESENT AT THE TIME OF SURGERY. PATIENT INFORMATION WILL NOT BE PROVIDED DUE TO CITED NATIONAL PRIVACY LAWS. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.