BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO LOCK SCRW,SS 2.7X 14MM

    MDR report key: 19478110 · Received June 6, 2024

    Report

    Report Number
    1220246-2024-05092
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    January 13, 2023
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047051
    PMA / PMN Number
    K143614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON 1/13/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 2 OF AN AR-8827L-14 LO-PRO LOCK SCREW HAD AN ISSUE. DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO LOCK THE SCREWS INTO THE PLATE, THEY KEPT SPINNING. BOTH SCREWS WERE REMOVED IN ONE PIECE, AND NOTHING BROKE INSIDE THE PATIENT. THE SURGEON USED THE BASEPLATE, MADE TWO HOLES NEXT TO THE ORIGINAL HOLES, AND USED TWO NON-LOCKING SCREWS AR-8827-14 LO-PRO SCREWS WITH UNKNOWN LOT NUMBERS INSTEAD. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE COMPLAINT DEVICES WERE DISCARDED AND NO PICTURES WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054910 LO-PRO LOCK SCRW,SS 2.7X 14MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO LOCK SCRW,SS 2.7X 14MM 14696485 00888867047051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown