BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 13625725 · Received February 28, 2022

    Report

    Report Number
    1038671-2022-00230
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    July 15, 2019
    Report Date
    February 28, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    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 (B)(6) 2020, EXACTECH, (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 NF ON (B)(6) 2020. (B)(4). 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. MOST LIKELY UNDERLYING CAUSE/ROOT CAUSE: PER (B)(4), THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT REPORTED IN (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. CORRECTIVE ACTION TAKEN: PER (B)(4), THE COMMITTEE HAS DETERMINED THAT THE DESIGN WILL BE UPDATED, TESTED, AND IMPLEMENTED, AFTER WHICH A STAGED MARKET WITHDRAWAL WAS CONDUCTED. PER (B)(4): A STOCK AUDIT WAS PERFORMED FOR THE DEVICES LOCATED IN 01 (COC). SEE (B)(4) FOR DETAILS. THE DESIGN WAS UPDATED TO INCREASE THE OVERLAP OF THE SNAP RING AND THE HOUSING LIP COMPONENTS. SEE (B)(4) 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: APPROPRIATE READING OF THE LITERATURE, AND TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR SURGERY, AND 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 MANUFACTURING ISSUES. THERE IS NO REPORTED PATIENT INJURY DUE TO THE DEVICE PIECE RETRIEVAL FROM THE SURGICAL SITE. PER (B)(4), THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT REPORTED IN CASE (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 A TOTAL KNEE ARTHROPLASTY SURGERY THE SURGEON EXPERIENCED AN ISSUE WITH THE INSTRUMENTATION. THE TIBIAL TAMP GUIDE HANDLE BUTTON THAT LOCKS THE HANDLE POPPED OFF WHILE IMPACTING THE PUNCH INTO THE TIBIA. ALL PIECES WERE CONFIRMED REMOVED FROM THE WOUND AND THE PATIENT. THERE WAS A DELAY, BUT THE PATIENT WAS NOT ADVERSELY AFFECTED. THERE IS NO REPORTED PATIENT INJURY DUE TO THE DEVICE PIECE RETRIEVAL FROM THE SURGICAL SITE. THE REP WAS PRESENT AT THE TIME OF SURGERY. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFORMATION FROM THE REP, BUT NO RESPONSES WERE RECEIVED. NO OTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS ABOUT THE DEVICE/EVENT/PATIENT. 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 MANUFACTURING ISSUES. THERE IS NO REPORTED PATIENT INJURY DUE TO THE DEVICE PIECE RETRIEVAL FROM THE SURGICAL SITE. PER (B)(4), THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT REPORTED IN (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943856 EXACTECH TRULIANT TIB TAMP GUIDE LXH EXACTECH, INC. 105607006

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Unknown Required Intervention