BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR, ASSEMBLY

    MDR report key: 13334019 · Received January 24, 2022

    Report

    Report Number
    1220246-2022-04333
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    October 28, 2021
    Report Date
    January 24, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867136731
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, ONE OF THE TWO CIRCULAR TABS BROKE OFF AT THE DISTAL END. THE PROXIMAL END IS ALSO WORN DUE TO IMPACTION. A LIKELY CAUSE OF THE BROKEN TAB IS USER-APPLIED MECHANICAL FORCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A UNIVERS REVERSE PROSTHESIS SURGERY THE BLUE PLASTIC PART OF THE DEVICE CAME OFF. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 05-NOV-2021: IT WAS CONFIRMED THAT THE BLUE PART GOT LOOSE AND FELL OFF AND DIDN`T BREAK OFF. UPDATE AVOE 10-JAN-2022: THE EVALUATION OF THE RETURNED DEVICE ON THE (B)(6) 2021 SHOWED THAT THE BLUE PART DID NOT COME OFF BUT THE TABS OF THE DEVICE BROKE-OFF. ON THE (B)(6) 2022 IT WAS CONFIRMED THAT THE BROKEN OFF TABS DID NOT RESULT DURING THE SHIPMENT TO INC, BUT THIS WAS WHAT THE CUSTOMER MEANT WITH DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629790 BASEPLATE IMPACTOR, ASSEMBLY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY 051908 00888867136731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown