BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14210226 · Received April 26, 2022

    Report

    Report Number
    1038671-2022-10080
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    May 29, 2018
    Report Date
    April 12, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    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. THE DEVICE WAS AVAILABLE FOR ANALYSIS. ENGINEERING ANALYSIS COMPLETED BY KN ON 3/15/2019. FINDINGS: THE PATELLAR CUP FRACTURED FROM NORMAL USE. MOST LIKELY UNDERLYING CAUSE: THE BROKEN PIECE WAS LIKELY THE RESULT OF MATERIAL DEGRADATION ASSOCIATED WITH YEARS OF NORMAL USE AND SUBSEQUENT STERILIZATION CYCLES. RMR REVIEW: 750-1992-001-RMR-INSTRUMENTS REV -, LINE 12. 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. DEVICE(S) 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. THE PATELLA CLAMP BROKE AND THE ACTIONS TAKEN WERE REPORTED AS "PULSLAVAGE BEFORE CLOSING, AND ANTIBIOTHERAPIE". AN INVESTIGATION WAS CONDUCTED: THE BROKEN PIECE WAS LIKELY THE RESULT OF MATERIAL DEGRADATION ASSOCIATED WITH YEARS OF NORMAL USE AND SUBSEQUENT STERILIZATION CYCLES.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM OUS THAT DURING AN ORTHOPEDIC SURGERY THE SURGEON EXPERIENCED AN ISSUE WITH THE CLAMP. THE PATELLA CLAMP BROKE WHILE CEMENTING THE IMPLANT. PULSLAVAGE BEFORE CLOSING, AND ANTIBIOTHERAPY FOR THE REST. "NOTHING SPECIAL." THE PATIENT'S HEALTH WAS STABLE LEAVING THE OPERATING ROOM. THE DEVICE WAS RETURNED ON 3/4/2019 ON RG301536. THE REP WAS PRESENT AT THE TIME OF SURGERY. NEW INFORMATION 1 JUL 2021: "THE INSTRUMENT COULD HAVE BEEN BROKEN DURING THE SURGERY. HOWEVER, THE BREAKAGE HAS BEEN NOTICED AT THE RECOVERY OF THE INSTRUMENTATION-SET BY OUR LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND [THE AGENCY] DIDN'T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL." NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528848 EXACTECH PATELLA CLAMP LXH EXACTECH, INC. 33049002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other