BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14013442 · Received April 5, 2022

    Report

    Report Number
    1038671-2022-00369
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    May 21, 2019
    Report Date
    April 5, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH, (B)(4), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. INFORMATION WAS NOT PROVIDED FOR: AGE OR DATE OF BIRTH, SEX, WEIGHT [76 NOT REPORTED KG OR POUNDS], ETHNICITY, RACE. FINDINGS: THE BUTTON COMPONENT (02-029-222-2005) OF THE TIBIAL TAMP GUIDE DISENGAGED FROM THE INSTRUMENT (02-029-22-2000). ENGINEERING PRINTS OF 02-029-122-2000 WERE REVIEWED. THE OVERLAP BETWEEN THE SNAP RING¿S OD AND THE ID OF THE HOUSING LIP IS .008 FOR THE WORST-CASE SCENARIO. ALTHOUGH THE OVERLAP IS POSITIVE, THE SMALL AMOUNT COULD CAUSE DISENGAGEMENT. CORRECTIVE ACTION: PER (B)(4), THE COMMITTEE HAS DETERMINED THAT THE DESIGN WILL BE UPDATED, TESTED, AND IMPLEMENTED, AFTER WHICH A STAGED MARKET WITHDRAWAL WILL BE CONDUCTED. IN THE MEANTIME, THE EXACTECH TEAM WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR THE ISSUE. CAPA(B)(4) IS STILL ONGOING AT THE TIME OF THIS EVALUATION, AND CORRECTIVE ACTIONS ARE SUBJECT TO CHANGE. REFER TO CAPA(B)(4) FOR MOST UP TO DATE INFORMATION. COMMENTS: WHEN INSPECTING THE INSTRUMENT, MOISTURE WAS FOUND IN THE WINDOW OF THE RETURNED DEVICE. THIS MOISTURE IS ADDRESSED IN (B)(4). THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT, AS DETERMINED BY CAPA(B)(4), WAS LIKELY THE RESULT OF INSUFFICIENT OVERLAP BETWEEN THE SNAP RING AND THE LIP OF THE HOUSING TO PREVENT THE OCCURRENCE OF DISENGAGEMENT. 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. THERE IS NO REPORTED PATIENT ADVERSE EVENT. NONE OF THE DEVICE PIECES WERE IN THE WOUND. THE WOUND WAS CLEANED OUT. ALL DEVICE PIECES WERE IDENTIFIED. THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT, AS DETERMINED BY CAPA(B)(4), WAS LIKELY THE RESULT OF INSUFFICIENT OVERLAP BETWEEN THE SNAP RING AND THE LIP OF THE HOUSING TO PREVENT THE OCCURRENCE OF DISENGAGEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE US THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON EXPERIENCED AN ISSUE WITH THE TIBIAL PUNCH. THE SURGEON PUNCHED THE TIBIA THEN HANDED THE PUNCH BACK TO THE TECH. AS THE TECH WAS PUTTING THE PUNCH BACK IN THE TRAY IT FELL APART. NONE OF THE DEVICE PIECES WERE IN THE WOUND. THE WOUND WAS CLEANED OUT. ALL DEVICE PIECES WERE IDENTIFIED. THE PATIENT WAS STABLE AS THEY LEFT THE OPERATING ROOM. THERE WAS NO DELAY TO SURGERY OR REPORTED PATIENT ADVERSE EVENT. THE AGENT WAS PRESENT AT THE SURGERY. INACTIVE AGENCY WITH NO HOSPITAL/OTHER CONTACT INFORMATION FOR THE EVENT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95854 EXACTECH TRULIANT TIB TAMP GUIDE LXH EXACTECH, INC. 82388001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown