BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14210216 · Received April 26, 2022

    Report

    Report Number
    1038671-2022-10062
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    July 27, 2018
    Report Date
    April 7, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. DEVICE WAS RECEIVED FOR ANALYSIS. ENG EVAL COMPLETED ON 10/10/2018 BY AD. CAPA2018-35 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 ROOT CAUSE PER CAPA2018-35, THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT WAS LIKELY THE RESULT OF INSUFFICIENT OVERLAP BETWEEN THE SNAP RING AND THE LIP OF THE HOUSING TO PREVENT THE OCCURRENCE OF DISENGAGEMENT. CORRECTIVE ACTION TAKEN: PER CRC2018-08-31-02, THE COMMITTEE HAS DETERMINED THAT THE DESIGN WILL BE UPDATED, TESTED, AND IMPLEMENTED, AFTER WHICH A STAGED MARKET WITHDRAWAL WAS CONDUCTED. PER CAPA(B)(4): A STOCK AUDIT WAS PERFORMED FOR THE DEVICES LOCATED IN 01 (COC). SEE NPR-40446 AND NPR-45222 FOR DETAILS. DEFECTIVE DEVICES WERE DISPOSITIONED FOR REWORK. THE DESIGN WAS UPDATED TO INCREASE THE OVERLAP OF THE SNAP RING AND THE HOUSING LIP COMPONENTS. SEE DCRTC-18-0401 AND DCRTC-19-0446 FOR DETAILS. THE DEFECTED DEVICES RETURNED FROM THE FIELD ARE TO BE REWORKED. SEE STAGED MARKET WITHDRAWAL OF TRULIANT TIBIAL TAMP GUIDE DOCUMENTED IN THE CAPA FOR DETAILS. 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. THE PATIENT WAS X-RAYED, AND IT WAS VERIFIED THAT THE MISSING SPRING WAS NOT RETAINED BY THE PATIENT. AN INVESTIGATION WAS CONDUCTED UNDER CAPA(B)(4); THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT 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 A BILATERAL TOTAL KNEE SURGERY THE SURGEON UTILIZED TRULIANT KNEE INSTRUMENTATION TO PREPARE THE KNEES TO ACCEPT TRULIANT POSTERIOR STABILIZED IMPLANTS. THE RIGHT KNEE WAS PREPPED FIRST. DURING PREPARATION OF THE RIGHT KNEE, WHEN THE TIBIAL TAMP HANDLE WAS HANDED TO THE SURGEON BY THE SURGICAL TECH, THE MODULAR TAMP HEAD FELL OFF THE HANDLE. THEY PUT IT BACK ON AND PROCEEDED WITH TAMPING THE TIBIA WITHOUT INCIDENT. THE LEFT KNEE WAS PREPPED AND THE TIBIAL TAMP USED WITHOUT INCIDENT. WHEN THE INSTRUMENTS WERE BROUGHT TO THE DECONTAMINATION ROOM FOR CLEANING, THE CLEANING PERSON NOTICED THAT THE TIBIAL TAMP HANDLE BUTTON WAS OUT OF POSITION, AND OUT OF THE HANDLE. THE SPRING THAT SITS BEHIND THE BUTTON IN THE HANDLE WAS MISSING. A CURSORY SEARCH FOR THE SPRING WAS MADE IN THE DECONTAMINATION ROOM. A MORE THOROUGH SEARCH WAS PLANNED FOR ON THE CLEAN SIDE (IN THE CLEAN ROOM). AT THIS POINT, IT WAS DETERMINED TO CHECK IF THE PATIENT WAS INVOLVED, BECAUSE THE SPRING WAS UNACCOUNTED FOR. THE SURGEON HAD LEFT THE HOSPITAL, THE PA WAS PRESENT AND CALLED FOR X-RAY REVIEW. THE SURGEON ALREADY HAD ORDERED POST-OPERATIVE X-RAYS. THE X-RAY REVIEW REVEALED NO EVIDENCE OF THE SPRING IN THE PATIENT. UPON FURTHER SEARCH FOR THE SPRING IN THE CLEAN ROOM THE SPRING WAS LOCATED. INACTIVE AGENCY, NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528838 EXACTECH TRULIANT TIBIAL TAMP GUIDE LXH EXACTECH, INC. 82388001

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other