BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH

    MDR report key: 14014082 · Received April 5, 2022

    Report

    Report Number
    1038671-2022-00375
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    August 16, 2019
    Report Date
    April 5, 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(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, ETHNICITY, AND 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 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 CAPA(B)(4): 1. A STOCK AUDIT WAS PERFORMED FOR THE DEVICES LOCATED IN 01 (COC). SEE NPR-40446 AND NPR-45222 FOR DETAILS. 2. THE DESIGN WAS UPDATED TO INCREASE THE OVERLAP OF THE SNAP RING AND THE HOUSING LIP COMPONENTS. 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 DUE TO THE DISENGAGED DEVICE. PER CAPA(B)(4), THE ROOT CAUSE FOR THE BUTTON DISENGAGEMENT REPORTED 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 INSTRUMENTATION. THE BUTTON POPPED OFF TIBIAL TAMP GUIDE DURING IMPACTION. THERE WAS NO DELAY TO THE SURGERY. THE PATIENT WAS NOT NEGATIVELY AFFECTED. THERE WAS NO REPORTED PATIENT INJURY. NO PIECES WERE LEFT IN THE PATIENT. THE REPRESENTATIVE WAS NOT PRESENT AT THE TIME OF THE SURGERY. THE DEVICE WAS RETURNED. 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
    813795 EXACTECH TRULIANT TIB TAMP GUIDE LXH EXACTECH, INC. 105607006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown