BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARUS® 3 LONG T15 HEXALOBE DRIVER

    MDR report key: 20802936 · Received November 27, 2024

    Report

    Report Number
    3025141-2024-00723
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 9, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER INFORMATION RECEIVED, IT WAS INDICATED THE DEVICE WAS AVAILABLE FOR EVALUATION. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED AT THE TIME OF THE PRODUCT'S RETURN AND EVALUATION.

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED POLARUS® 3 LONG T15 HEXALOBE DRIVER (PART NUMBER 80-1618, BATCH NUMBER 430898) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. THE DRIVER HAD SIGNS OF WEAR AT THE TIP. NEITHER THE SCREW OR THE LOCKING NAIL WERE RETURNED. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTED DATA: TYPE OF INVESTIGATION CODE (ANNEX B): UPDATED 3331 AND 10.

    Description of Event or Problem · 0

    (REPORT 1 OF 3). IT WAS REPORTED DURING SURGERY THAT WHEN THE SURGEON TRIED TO REMOVE IMPLANTED POLARUS® 3 LOCKING NAIL 240MM WITH A POLARUS® 3 LONG T15 HEXALOBE DRIVER, ONE OF THE LOW PROFILE HEXALOBE SCREWS WAS STRIPPED. BOTH THE NAIL AND THE SCREW COULD NOT BE REMOVED, THEREFORE REMAIN IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED WITH NO DELAY. NO OTHER PATIENT CONSEQUENCES WERE REPORTED. IT WAS ALSO REPORTED IT WAS UNDECIDED WHETHER TO REMOVE THEM BY REOPERATION OR LEAVE THEM AS THEY ARE. THE PRIMARY SURGERY WAS ABOUT 5 YEARS AGO, BUT THE SPECIFIC DATE IS UNKNOWN. THERE ARE 3 RELATED REPORT NUMBERS FOR THIS EVENT 3025141-2024-00723 - 3025141-2024-00725.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446377 POLARUS® 3 LONG T15 HEXALOBE DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-1618 430898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown