BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 13949481 · Received March 30, 2022

    Report

    Report Number
    1038671-2022-00317
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    July 15, 2019
    Report Date
    April 25, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 (B)(4), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. ENGINEERING ANALYSIS COMPLETED BY (B)(4) ON 9/17/2019. (B)(4) AND CAPA(B)(4). FINDINGS: IN THE CASE OF MULTI-PIECE CONSTRUCTION, IT WAS FOUND THAT THE WELD ON THE EXTRACTOR BODY WAS BREAKING. THIS ALLOWED THE COMPONENT PARTS TO DISASSEMBLE. THE ENGINEERING PRINT FOR THE FEMORAL TRIAL EXTRACTOR (02-029-219-1202 REV A) ALLOWED FOR ¿SINGLE OR MULTIPLE PIECE CONSTRUCTION¿ (NOTE 2). HOWEVER, THE PRINT DID NOT SPECIFY HOW TO WELD/ASSEMBLE THE DEVICE IF MULTIPLE-PIECE CONSTRUCTION WAS TO BE USED. MOST LIKELY UNDERLYING CAUSE/ROOT CAUSE: BASED ON THE CAPA AND CRC, THE BROKEN DEVICE REPORTED IN (B)(4) WAS LIKELY THE RESULT OF AN INSUFFICIENT WELD ON 02-029-219-1202 REV A, WHICH LED TO WELD FRACTURE AND COMPONENT DISASSEMBLY. CORRECTIVE ACTION TAKEN: PARTS WILL NOT BE ORDERED UNLESS THEY ARE MANUFACTURED AS A SINGLE PIECE CONSTRUCTION. REFER TO CAPA(B)(4). 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 MANUFACTURING ISSUES. THERE IS NO REPORTED PATIENT ADVERSE EVENT. THE DEVICE CAN FRACTURE AND DISASSEMBLE. BASED ON (B)(4) AND CAPA(B)(4), THE BROKEN DEVICE REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT WELD ON 02-029-219-1202 REV A, WHICH LED TO WELD FRACTURE AND COMPONENT DISASSEMBLY. INFORMATION WAS NOT PROVIDED FOR: PT. INFO.

    Additional Manufacturer Narrative · 0

    H11. AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH, FEI (B)(6), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. THIS MEDWATCH IS BEING RESCINDED: UPON FURTHER REVIEW OF REPORTABILITY- IF THE MALFUNCTION WERE TO RECUR, IT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. THE DISASSEMBLED PARTS ARE NOT LIKELY TO FALL INTO THE WOUND SITE OR INTERFERE WITH THE SURGICAL IMPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE US THAT THE TRIAL EXTRACTOR BROKE DURING A TOTAL KNEE ARTHROPLASTY SURGERY. THE FEMUR TRIAL EXTRACTOR BROKE AT THE JUNCTION OF THE TWO PRONGS THAT HOOK INTO THE TRIAL WHILE BACKSLAPPING THE TRIAL OFF. THERE WAS A DELAY, BUT THE PATIENT WAS NOT ADVERSELY AFFECTED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFORMATION FROM THE REPRESENTATIVE, BUT NO RESPONSES WERE RECEIVED. THERE IS NO OTHER INFORMATION ABOUT THE DEVICE OR EVENT FROM THE CONTACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760059 EXACTECH TRUL FEM TRIAL EXTRACTOR LXH EXACTECH, INC. 093583004

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Unknown Other