BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14286213 · Received May 5, 2022

    Report

    Report Number
    1038671-2022-10112
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    November 19, 2019
    Report Date
    May 3, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH, FEI (B)(4), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. ENG EVAL ATTACHED BY MV TO SS ON (B)(6) 2020. ALTHOUGH STILL UNDER THE THRESHOLD OF <0.5% FOR VERY LOW' OCCURRENCE RATE, DUE TO A TREND OF THE RECENT COMPLAINTS HAVING APPROXIMATELY A 5X HIGHER OCCURRENCE RATE IN THE KOREAN MARKET, (B)(4) AND CAPA (B)(4) WERE ESTABLISHED TO INVESTIGATE ADDITIONAL POTENTIAL CAUSES OF THE HIGHER OCCURRENCE RATE SPECIFIC TO THE KOREAN MARKET. PREVIOUSLY, CAPA(B)(4) IDENTIFIED IMPROPER REPROCESSING PROCEDURES AS A ROOT CAUSE FOR A HIGHER INCIDENCE OF FRACTURED RADEL TIBIAL INSERT TRIALS IN KOREA AND SINGAPORE. BECAUSE THE DEVICES INVESTIGATED IN CAPA (B)(4) ARE MADE FROM THE SAME TYPE OF MATERIAL AS THE HUMERAL LINER IMPACTOR TIPS AND THE GEOGRAPHIC LOCATION OF THE FAILURES IS THE SAME, CAPA (B)(4) IS INVESTIGATING THE POSSIBILITY OF A SIMILAR CORRELATION BETWEEN THE HIGHER INCIDENCE OF FRACTURES AND THE REPROCESSING PROCEDURE FOR THE IMPACTOR TIPS. IF THE BROKEN PIECE IS LEFT IN THE PATIENT'S WOUND WITHOUT BEING NOTICED, IT COULD CAUSE INJURY TO THE PATIENT AND WOULD REQUIRE PROFESSIONAL MEDICAL INTERVENTION. THE MATERIAL OF THESE INSTRUMENTS, RADEL PER ETS-0205, IS INCLUDED IN THE BIOCOMPATIBILITY ASSESSMENT TECHNICAL MEMO, TM-2013-465. RADEL PASSES THE BIOCOMPATIBILITY REQUIREMENTS FOR SURGICAL USE, AND THERE ARE NO ANTICIPATED ADVERSE HEALTH CONSEQUENCES. THE NEED FOR ANY CORRECTION ACTIONS WILL BE DETERMINED BY CAPA(B)(4). MOST LIKELY UNDERLYING CAUSE/ROOT CAUSE: BASED ON INFORMATION AVAILABLE AT THIS TIME, NO CONCLUSION CAN BE MADE REGARDING THE HIGHER MARKET SPECIFIC OCCURRENCE. ADDITIONAL INVESTIGATION FOR A MOST LIKELY UNDERLYING CAUSE/ROOT CAUSE RELATED TO MARKET SPECIFIC OCCURRENCE IS STILL ONGOING. REFER TO CAPA(B)(4) FOR ADDITIONAL INFORMATION. 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: APPROPRIATE READING OF THE LITERATURE, AND TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR SURGERY, AND 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 AND/OR DESIGN ISSUES. NONE OF THE BROKEN PARTS/PIECES FELL INTO THE SURGICAL SITE AND THERE WAS NO ADVERSE EVENT TO THE PATIENT. AN INVESTIGATION WAS CONDUCTED UNDER CAPA2020-01; BASED ON INFORMATION AVAILABLE AT THIS TIME, NO CONCLUSION CAN BE MADE REGARDING THE HIGHER MARKET SPECIFIC OCCURRENCE. ADDITIONAL INVESTIGATION FOR A MOST LIKELY UNDERLYING CAUSE/ROOT CAUSE RELATED TO MARKET SPECIFIC OCCURRENCE IS STILL ONGOING.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM OUS THAT DURING AN ORTHOPEDIC SURGERY THE IMPACTOR TIP BROKE. WHILE USING THE 38MM IMPACTOR TIP TO IMPACT THE 38MM LINER, THE TIP BROKE IN HALF. THE SURGEON DECIDED TO GO TO THE 42MM OPTION AND OPERATION PROCEEDED WITHOUT FURTHER INCIDENT. THERE WERE NO PARTS/PIECES OF THE BROKEN DEVICE THAT FELL INTO THE PATIENT WOUND. THERE WAS NO SURGICAL DELAY OR ANY ADVERSE EVENT TO THE PATIENT. THERE ARE NO REPORTED RESULTS ABOUT THE PATIENT'S OVERALL OUTCOME. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442567 EXACTECH 38MM BLUE IMPACTOR TIP LXH EXACTECH, INC. 71041004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other