BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOXE

    MDR report key: 9115199 · Received September 25, 2019

    Report

    Report Number
    1038671-2019-00467
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    July 3, 2019
    Report Date
    January 27, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862085313
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THIS BROKEN TRI-DRIVE REPORTED WAS LIKELY THE RESULT OF HOLDING THE SLEEVE STATIONARY WHILE THE INSTRUMENT WAS SPINNING OR THE TRI-DRIVE CONTACTING A RETRACTOR, WHICH LED TO THE RETAINING RING BREAKING LOOSE FROM THE ASSEMBLY, ALLOWING THE TIP TO DISASSEMBLE. CAPA 2019-44 HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. (H6) EVALUATION CODES: 2199, 1069. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 05-JUL-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS USING THE MODULAR DRIVER TO REAM THE GLENOID WHEN THE SPRING-LOADED END CONNECTOR CAME APART. THE COLLAR, SPRING, AND BALL BARRING FELL OFF THE DRIVER. THE PATIENTS¿ HEALTH WAS NOT COMPROMISED. ALL PARTS OF THE DRIVER WERE TAKEN OUT BEFORE THE SURGEON CLOSED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915332 EQUINOXE MDLR CNLTD TRIDRV DRVR KWT EXACTECH, INC. UNK 10885862085313

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R