BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 13953643 · Received March 30, 2022

    Report

    Report Number
    1038671-2022-00329
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    April 10, 2019
    Report Date
    March 30, 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 1038671, HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. DESIGN-RELATED ISSUES: THE DESIGN OF THE LOGIC CR TIBIAL INSERT TRIAL HAS BEEN IN THE FIELD SINCE 2012. EXACTECH IS AWARE OF 6 COMPLAINT REPORTS INVOLVING A FRACTURED TIBIAL INSERT TRIAL EXTRACTION FEATURE SINCE 2012. SALES DATA FOR TIBIAL INSERTS WAS USED TO CALCULATE AN APPROXIMATE COMPLAINT OCCURRENCE RATE OF <0.5%. THIS IS CONSIDERED ¿VERY LOW¿ ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE DESIGN RELATED. MFG-RELATED ISSUES: EXACTECH IS NOT AWARE OF ANY OTHER COMPLAINTS INVOLVING PARTS FROM THIS MANUFACTURING LOT OF 14 UNITS, WHICH HAS BEEN IN THE FIELD SINCE 2014. THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT (RMR) WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESHOLD. THE RMR FOR THESE LOGIC TIBIAL INSERT TRIALS, 750-2010-016-RMR-INSTRUMENTS REV -, WAS REVIEWED. THE RISK IS CAPTURED IN LINE 13. CORRECTIVE ACTIONS ARE NOT REQUIRED BECAUSE THE OCCURRENCE RATE IS ¿VERY LOW¿, AND THE RISK IS CAPTURED IN THE RMR. THE BROKEN TIBIAL INSERT TRIAL REPORTED WAS LIKELY THE RESULT OF APPLYING EXCESS FORCE TO THE EXTRACTION FEATURE WHICH LED TO CRACK INITIATION, PROPAGATION, AND ULTIMATE FAILURE. 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. THERE IS NO REPORTED PATIENT ADVERSE EVENT DUE TO THE FRACTURED TRIAL. AN INVESTIGATION WAS CONDUCTED: THE BROKEN TIBIAL INSERT TRIAL REPORTED WAS LIKELY THE RESULT OF APPLYING EXCESS FORCE TO THE EXTRACTION FEATURE WHICH LED TO CRACK INITIATION, PROPAGATION, AND ULTIMATE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM OUS THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON EXPERIENCED AN ISSUE WITH THE TRIAL. THE TRAIL WAS DAMAGED BY A SURGEON USING A HOHMANN RETRACTOR TO REMOVE IT. NO ISSUE TO THE PATIENT OCCURRED DURING THIS CASE. THE REPRESENTATIVE WAS PRESENT. THE DEVICE WAS RETURNED. PER THE REPRESENTATIVE, NO PIECE OF THE TRIAL WAS LEFT IN OR RETRIEVED FROM THE PATIENT. THE TRIAL WAS REMOVED IN AN ENTIRE PIECE. NO DELAY TO SURGERY. NO PROBLEMS POST-OP. PATIENT DEMOGRAPHICS ARE NOT AVAILABLE. THERE IS NO ADDITIONAL INFORMATION ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189444 EXACTECH LOGIC CR INSERT TRIAL SIZE 3.5, NEUTRAL, 9 MM LXH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown