BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARUS® 3 LONG T15 HEXALOBE DRIVER

    MDR report key: 7539193 · Received May 23, 2018

    Report

    Report Number
    3025141-2018-00210
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 11, 2018
    Manufacturer
    ACUMED LLC
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2018-00208: DRILL GUIDE. 3025141-2018-00209: DRILL.

    Description of Event or Problem · 1

    WHEN IMPLANTING A POLARUS 3 HUMERAL NAIL, THE SURGEON EXPERIENCED THE FOLLOWING ISSUES WITH THE INSTRUMENTATION FOR THE PRODUCT. THIS CAUSED A 2 HOUR DELAY IN SURGERY TIME. THE SHORT DRILL IS TOO LONG. (P/N 80-1592). THE T15 DRIVER TIP DOES NOT HOLD THE SCREWS SECURELY, ALLOWING THEM TO POP OFF DURING CRUCIAL IMPLANTATION (P/N 80-1618). THERE IS NO SOFT TISSUE PROTECTOR FOR THE DISTAL DRILL GUIDE. (P/N 80-1587).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381979 POLARUS® 3 LONG T15 HEXALOBE DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, DRIVER LXH ACUMED LLC 80-1618

    Patients

    Seq Age Sex Outcome Treatment
    1