BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM FLEX DRILL, KNOTLESS HIP FIBERTAK

    MDR report key: 19380435 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03697
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    December 16, 2021
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867298026
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 12/16/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THREE AR-3602H ANCHORS PULLED OUT OF THE BONE DURING A HIP ARTHROSCOPY. THE FIRST ONE PULLED OUT OF THE BONE WHEN IT WAS SET. IT WAS REPLACED AND THE SAME EVENT OCCURRED. A THIRD ANCHOR WAS USED BUT ONCE AGAIN PULLED OUT. THE ANCHORS WERE REPLACED WITH A NON ARTHREX PRODUCTS AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE CASE INVOLVED A 32 YEAR OLD FEMALE AND, AS OF TODAY SHE IS FINE. THE REP IS ALSO RETURNING THE AR-3600ND-2H DRILL BIT TO BE INSPECTED ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749678 8MM FLEX DRILL, KNOTLESS HIP FIBERTAK DRILL BIT HTW ARTHREX, INC. 8MM FLEX DRILL, KNOTLESS HIP FIBERTAK 13855059 00888867298026

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female