BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 DRIVER, RETAINING

    MDR report key: 19384301 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03761
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    August 30, 2022
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00848665039320
    PMA / PMN Number
    K202489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. COMPLAINT CONFIRMED. UPON VISUAL INSPECTION IT WAS NOTED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED 5042-100 HAD TWISTED. NO FRAGMENTS WERE RETURNED FOR INSPECTION. IT WAS NOT INDICATED IF A TORQUE-INDICATING ADAPTER HAD BEEN USED WITH THE DEVICE. THE MOST LIKELY CAUSE OF THE FAILURE IS USE ERROR DUE TO EXCESSIVE FORCE ON THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 08/30/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 5042-100 AND 5025-300 DRIVERS ARE BENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12109 T10 DRIVER, RETAINING ORTHOPEDIC MANUAL SURG INSTR HRS ARTHREX, INC. T10 DRIVER, RETAINING 220340 00848665039320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown